Phathom Pharmaceuticals, Inc.
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data from SEC XBRL filings. Values are as-reported; restatements supersede originals. Values reported in .
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f Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the unaudited interim condensed financial statements and notes thereto included in this Quarterly Report on Form 10-Q and with our audited financial statements and notes thereto for the year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2025, or the 2025 Form 10-K.
Forward Looking Statements
The following discussion and other parts of this quarterly report contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this quarterly report, including statements regarding our future results of operations and financial position, business strategy, commercialization plans and costs, research and development plans and costs, pricing and reimbursement, the potential to develop future product candidates, the timing and likelihood of success of the plans and objectives of management for current and future operations, and future results of planned commercialization activities, product development and other efforts, are forward-looking statements. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “estimate,” or “continue,” and similar expressions or variations. The forward-looking statements in this quarterly report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, operating results, business strategy, short-term and long-term business operations and objectives. These forward-looking statements speak only as of the date of this quarterly report and are subject to a number of risks, uncertainties and assumptions, including those described in the Part I, Item 1A under the heading “Risk Factors” of our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Overview
We are a commercial-stage biopharmaceutical company focused on commercializing and developing novel treatments for gastrointestinal, or GI, diseases. Our approved products, VOQUEZNA®, VOQUEZNA DUAL PAK® and VOQUEZNA TRIPLE PAK®, contain vonoprazan, an oral small molecule potassium-competitive acid blocker, or PCAB. PCABs are a novel class of molecules that block acid secretion in the stomach. VOQUEZNA is the only PCAB currently approved for marketing and sale in the United States.
We began U.S. commercialization of VOQUEZNA for the treatment of erosive gastroesophageal reflux disease, or Erosive GERD, and Helicobacter pylori, or H. pylori, infection, and VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK for the treatment of H. pylori infection in November 2023. The U.S. Food and Drug Administration, or FDA, approved VOQUEZNA for the relief of heartburn associated with Non-Erosive GERD, the largest category of GERD, in July 2024.
Vonoprazan was originally developed by Takeda Pharmaceutical Company Limited, or Takeda, and is marketed in multiple countries outside the United States. We licensed U.S., European and Canadian rights to vonoprazan from Takeda in 2019. We are independently commercializing VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK in the United States.
During the nine months ended September 30, 2026, we generated increased revenues from sales of our VOQUEZNA products compared to the same period in the prior year, reflecting continued execution of our U.S. commercial strategy. The majority of our revenue was derived from sales of VOQUEZNA. During this period, we also experienced growth in prescription volume and prescriber adoption, with most prescriptions written for GERD indications. As of October 16, 2026, over 2 million prescriptions for VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK have been filled since launch. We continue to have broad commercial coverage for VOQUEZNA, with access for over 120 million, or over 80%, of U.S. commercial lives. Our commercial efforts are supported by a targeted sales force and continued focus on prescriber engagement and payer access.
In May 2021, the FDA granted qualified infectious disease product, or QIDP, designation to VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK, resulting in an extension of the five-year new chemical entity, or NCE, exclusivity by an additional five years. In December 2024, we submitted a citizen petition requesting that the FDA update the Orange Book listing for VOQUEZNA to reflect the same
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ten-year period of NCE exclusivity applicable to VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK. In June 2025, the FDA granted the petition and updated the Orange Book listing for VOQUEZNA to reflect the ten-year period of NCE exclusivity for vonoprazan. As a result, all three VOQUEZNA products now have NCE exclusivity extending through May 3, 2032.
In the fourth quarter of 2025, we initiated a Phase 2 clinical trial evaluating vonoprazan in the treatment of adults with eosinophilic esophagitis, or EoE. In June 2026, we announced that we completed enrollment ahead of schedule in the Phase 2 EoE clinical trial study. The study has enrolled 95 patients at 41 U.S. sites. Topline results from the 12-week blinded treatment portion of the trial are expected to be reported during the fourth quarter of 2026.
In September 2026, we announced the initiation of pHalcon-NERD-302, a registrational Phase 3 study evaluating an as-needed (PRN or on-demand) investigational dosing regimen of VOQUEZNA tablets in adults with Non-Erosive Gastroesophageal Reflux Disease, or Non-Erosive GERD (NERD). Topline results are expected during the first quarter of 2028. If successful, the study is intended to support a potential regulatory submission seeking a label expansion for VOQUEZNA tablets for this treatment regimen.
While our current focus is on continued U.S. commercialization of VOQUEZNA products for GERD and H. pylori, we are also selectively evaluating other life-cycle management opportunities for vonoprazan. We may also explore the potential for vonoprazan in Europe and Canada, as well as opportunities to in-license or acquire additional clinical or commercial-stage product candidates for GI diseases.
We commenced our operations in 2018 and have devoted substantially all of our resources to date to organizing and staffing our company, business planning, raising capital, in-licensing vonoprazan, meeting with regulatory authorities, managing our clinical trials of vonoprazan, preparing for commercialization of our products containing vonoprazan, commercially launching our approved products in the U.S., and providing other selling, general and administrative support for our operations. Our operations to date have been funded primarily through commercial bank debt, our revenue interest financing debt and various equity offerings, including our at-the-market offerings. From inception through September 30, 2026, we sold 41,612,032 shares of common stock and 3,859,000 pre-funded warrants, generating net proceeds of approximately $665.3 million, after deducting underwriting discounts, commissions and offering costs.
As of September 30, 2026, we had cash and cash equivalents of $184.6 million. Based on our current operating plan, we believe that our existing cash and cash equivalents together with our anticipated product revenues, are sufficient to fund operations for at least the next twelve months. We have based these estimates on assumptions that may prove to be incorrect, and, if operating results, commercial performance or expenses differ materially from those contemplated by our current operating plan, our capital resources, together with anticipated product revenues, may not be sufficient to fund operations and our cash needs for as long as we currently expect. In such event, we may need to seek additional funds sooner than planned, through public or private equity or debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Additional financing or other capital may not be available on favorable terms, or at all, and our failure to obtain additional capital, if and when needed, could adversely affect our financial condition and require us to delay, limit, reduce or terminate development or commercialization activities or grant rights to products or product candidates that we would otherwise prefer to retain.
Since inception, we have incurred significant operating losses. Our net losses were $61.8 million and $200.1 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $1.5 billion. If we do not achieve our operating plan or, if our revenues or expenses differ materially from our current expectations, we may continue to incur operating losses longer than we currently anticipate.
Restructuring
In May 2025, we implemented a cost reduction and organizational restructuring plan to reduce cash burn and focus resources on commercial execution. In connection with the restructuring, our workforce was reduced by 26 employees, or approximately 6%, including certain leadership changes all designed to right-size the organization. In 2025, total restructuring charges incurred were $9.2 million consisting of one-time termination benefits to affected employees for severance, non-cash stock-based compensation costs, healthcare benefits and outplacement assistance. As of September 30, 2026, we have paid substantially all of the accrued restructuring charges.
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License Agreement with Takeda
On May 7, 2019, we and Takeda entered into an exclusive license, or the Takeda License, pursuant to which we in-licensed the U.S., European, and Canadian rights to vonoprazan fumarate. During the term of the Takeda License, we and our affiliates are not permitted to commercialize any pharmaceutical product, other than vonoprazan, that treats acid-related disorders, except for certain generic and OTC competing products in specified circumstances. We are responsible at our cost for our development, manufacture and commercialization of vonoprazan products. We are required to use commercially reasonable efforts to develop and commercialize the vonoprazan products in our licensed territory.
Under the Takeda License, Takeda has the sole right and authority, with our input, to prepare, file, prosecute, and maintain all Takeda and joint patents on a worldwide basis at its own cost. We are responsible, at our cost, for preparing, filing, prosecuting, and maintaining patents on inventions made solely by us in connection with vonoprazan, subject to input from Takeda.
We paid Takeda upfront consideration consisting of a cash fee of $25 million, 1,084,000 shares of our common stock, a warrant to purchase 7,588,000 shares of our common stock at an exercise price of $0.00004613 per share, or the Takeda Warrant, and issued Takeda a right to receive an additional common stock warrant, or the Takeda Warrant Right, if Takeda’s fully-diluted ownership of the Company represented less than a certain specified percentage of the fully-diluted capitalization, including shares issuable upon conversion of then outstanding convertible promissory notes, calculated immediately prior to the closing of our IPO. The Takeda Warrant Right expired without effect since no fair value had been allocated to it upon completion of our IPO, and no additional warrant was issued. We agreed to make milestone payments to Takeda upon achieving certain tiered aggregate annual net sales of licensed products in the United States, Europe and Canada up to a total maximum milestone amount of $250 million. We also agreed to make tiered royalty payments at percentages averaging in the low double digits on net sales of licensed products, subject to specified offsets and reductions. Royalties are payable, on a product-by-product and country-by-country basis from the first commercial sale of such product in such country, until the latest of expiration of the licensed patents covering the applicable product, expiration of regulatory exclusivity in such country, or 15 years following first commercial sale in such country. We currently pay royalties to Takeda on sales of VOQUEZNA tablets, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK in the U.S. During the three months ended September 30, 2026 and 2025, we recorded $8.5 million and $5.0 million, respectively, of royalty expense under the Takeda License, of which $8.5 million is included within accrued expenses as of September 30, 2026. During the nine months ended September 30, 2026 and 2025, we recorded $21.7 million and $11.8 million, respectively, of royalty expense under the Takeda License.
Components of Results of Operations
Revenue
We began to recognize revenue from product sales, net of rebates, chargebacks, sales returns, discounts, and other adjustments, in November 2023 in conjunction with the commercial launch of VOQUEZNA, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK in the United States.
Cost of Revenue
Cost of revenue includes the cost of producing and distributing inventories that are related to product sales. This also includes royalties payable to Takeda, pursuant to the Takeda License (Refer to Note 3 for further details). In addition, shipping and handling costs for product sales along with fulfillment costs are recorded as incurred. Cost of revenue also includes costs related to excess or obsolete inventory adjustment charges.
Operating Expenses
Research and Development
To date, our research and development expenses have related to the development of vonoprazan. Research and development expenses are recognized as incurred and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. We do not track total research and development expenses by indication.
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Research and development expenses include:
The following table summarizes our research and development expenses for the three and nine months ended September 30, 2026 and 2025 (in thousands):
|
Three Months Ended |
Nine Months Ended |
||||||||||
|
2026 |
|
|
2025 |
2026 |
|
|
2025 |
||||
Clinical development and regulatory |
$ |
5,263 |
|
|
$ |
1,410 |
$ |
13,687 |
|
|
$ |
7,405 |
Personnel related |
|
2,058 |
|
|
|
2,127 |
|
6,531 |
|
|
|
8,974 |
Chemistry manufacturing and controls |
|
319 |
|
|
|
1,397 |
|
704 |
|
|
|
2,903 |
Consulting, professional and other costs |
|
277 |
|
|
|
30 |
|
655 |
|
|
|
962 |
Stock-based compensation |
|
828 |
|
|
|
2,063 |
|
2,753 |
|
|
|
5,043 |
Total research and development expenses |
$ |
8,745 |
|
|
$ |
7,027 |
$ |
24,330 |
|
|
$ |
25,287 |
We plan to invest in research and development for the foreseeable future as we continue the development of vonoprazan and potentially in the future also develop additional product candidates. We cannot determine with certainty the timing, duration or costs of ongoing or future clinical trials and nonclinical studies of vonoprazan or any future product candidates due to the inherently unpredictable nature of clinical and preclinical development. Clinical and preclinical development timelines, the probability of success, actual results and development costs can differ materially from expectations. In addition, we cannot forecast which product candidates, if any, may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans, expenses and capital requirements.
Selling, General and Administrative
Selling, general and administrative expenses consist of salaries and employee-related costs, including stock-based compensation, for personnel in commercial, executive, finance, accounting, legal, human resources and other administrative functions, restructuring expenses in 2025, legal fees relating to intellectual property and corporate matters, and professional fees for accounting and consulting services.
Other Income and Expense
Interest Income
Interest income consists of interest on our money market funds.
Interest Expense
Revenue Interest Financing Agreement
Interest expense under the Revenue Interest Financing Agreement (as further described below under Liquidity and Capital Resources) is based on the imputed effective interest rate derived from expected future payments and the carrying value of the
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obligation. We recalculate the effective interest rate each period based on the current carrying value and the revised estimated future payments. Changes in future payments from previous estimates are included in current and future interest expense.
Loan Agreement with Hercules
Beginning on February 25, 2026, interest expense under our Loan and Security Agreement, or the Loan Agreement, with Hercules Capital, Inc., or Hercules, in its capacity as administrative agent and collateral agent and as a lender, consists of (i) cash interest at a variable annual rate equal to the greater of (a) 9.85% and (b) the Prime Rate (as reported in the Wall Street Journal) plus 3.10%, and (ii) amortization of the Loan Agreement debt discount recorded in connection with the fair value of warrants issued to the lenders, the debt issuance costs incurred, and the obligation to make a final payment.
From December 14, 2023 through February 25, 2026, interest expense under the Loan Agreement consisted of (i) cash interest at a variable annual rate equal to the greater of (a) 9.85% and (b) the Prime Rate (as reported in the Wall Street Journal) plus 1.35% and provided that the cash interest rate was to be capped at 10.35% and upon achieving certain milestones, the cash interest was to decrease by 0.35%, (ii) payment-in-kind interest was at a per annum rate of interest equal to 2.15%, and (iii) amortization of the Loan Agreement debt discount recorded in connection with the fair value of warrants issued to the lenders, the debt issuance costs incurred, and the obligation to make a final payment.
Results of Operations
Comparison of the Three Months Ended September 30, 2026 and 2025
The following table summarizes our results of operations for the three months ended September 30, 2026 and 2025 (in thousands):
|
Three Months Ended |
|
|
|
||||||
|
2026 |
|
|
2025 |
|
Change |
|
|||
Product revenue, net |
$ |
84,722 |
|
|
$ |
49,504 |
|
$ |
35,218 |
|
Cost of revenue |
|
18,367 |
|
|
|
6,190 |
|
|
12,177 |
|
Gross profit |
|
66,355 |
|
|
|
43,314 |
|
|
23,041 |
|
Operating expenses: |
|
|
|
|
|
|
|
|||
Research and development |
|
8,745 |
|
|
|
7,027 |
|
|
1,718 |
|
Selling, general and administrative |
|
57,695 |
|
|
|
51,558 |
|
|
6,137 |
|
Total operating expenses |
|
66,440 |
|
|
|
58,585 |
|
|
7,855 |
|
Loss from operations |
|
(85 |
) |
|
|
(15,271 |
) |
|
15,186 |
|
Other (expense) income: |
|
|
|
|
|
|
|
|||
Interest income |
|
1,600 |
|
|
|
1,413 |
|
|
187 |
|
Interest expense |
|
(15,387 |
) |
|
|
(16,108 |
) |
|
721 |
|
Other expense, net |
|
(25 |
) |
|
|
(7 |
) |
|
(18 |
) |
Total other expense |
|
(13,812 |
) |
|
|
(14,702 |
) |
|
890 |
|
Net loss |
$ |
(13,897 |
) |
|
$ |
(29,973 |
) |
$ |
16,076 |
|
Revenue. Product revenues were $84.7 million and $49.5 million for the three months ended September 30, 2026 and 2025, respectively, related to sales of VOQUEZNA, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK which were launched in the fourth quarter of 2023. The increase of $35.2 million was due to continued execution of our commercial strategy.
Cost of Revenue. Cost of revenue was $18.4 million and $6.2 million for the three months ended September 30, 2026 and 2025, respectively. The increase of $12.2 million was due to the increase in revenues and the corresponding increase in Takeda royalties incurred, as well as increased fulfillment costs.
Research and Development Expenses. Research and development expenses were $8.7 million and $7.0 million for the three months ended September 30, 2026 and 2025, respectively. The increase of $1.7 million consists of an increase of $3.9 million of higher clinical development and regulatory costs offset by $1.3 million of lower personnel-related expenses and $0.9 million of lower CMC costs.
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Selling, General and Administrative Expenses. Selling, general and administrative expenses were $57.7 million and $51.6 million for the three months ended September 30, 2026 and 2025, respectively. The increase of $6.1 million was primarily related to a $3.6 million increase in advertising and promotional expenses, and an increase of $2.5 million of personnel-related expenses.
Other (Expense) Income. Other expense of $13.8 million for the three months ended September 30, 2026 consisted of $15.4 million of interest expense under the Loan Agreement and Revenue Interest Financing Agreement, partially offset by $1.6 million of interest income related to cash held in money market funds. Other expense of $14.7 million for the three months ended September 30, 2025 consisted of $16.1 million of interest expense under the Loan Agreement and Revenue Interest Financing Agreement, partially offset by $1.4 million of interest income related to cash held in money market funds.
Comparison of the Nine Months Ended September 30, 2026 and 2025
The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025 (in thousands):
|
Nine Months Ended |
|
||||||
|
2026 |
|
|
2025 |
Change |
|||
Product revenue, net |
$ |
217,297 |
|
|
$ |
117,526 |
$ |
99,771 |
Cost of revenue |
|
45,458 |
|
|
|
14,951 |
|
30,507 |
Gross profit |
|
171,839 |
|
|
|
102,575 |
|
69,264 |
Operating expenses: |
|
|
|
| ||||
Next expected filings
- ~2027-02-25 10-K expected by 2027-03-07 (in 119 days)
- ~2027-04-29 10-Q expected by 2027-05-01 (in 182 days)
- ~2027-07-29 10-Q expected by 2027-07-31 (in 273 days)
- ~2027-10-28 10-Q expected by 2027-10-30 (in 364 days)
Predicted from historical filing cadence; not an SEC commitment.
Recent SEC filings
- 2026-10-29 10-Q Quarterly Report
- 2026-10-29 8-K Earnings Release; Financial Statements and Exhibits
- 2026-10-26 8-K Other Events
- 2026-10-23 8-K Other Events
- 2026-09-29 8-K Other Events
- 2026-07-30 10-Q Quarterly Report
- 2026-07-30 8-K Earnings Release; Financial Statements and Exhibits
- 2026-06-23 8-K Other Events
- 2026-04-30 10-Q Quarterly Report
- 2026-04-30 8-K Earnings Release; Financial Statements and Exhibits
- 2026-04-07 DEF 14A Proxy Statement
- 2026-02-26 10-K Annual Report
- 2026-02-26 8-K Earnings Release; Financial Statements and Exhibits
- 2026-01-08 8-K Other Events; Financial Statements and Exhibits
- 2026-01-07 8-K Earnings Release; Financial Statements and Exhibits