HRTX — what changed in the latest 10-Q
A section-by-section comparison of HRTX's newest periodic SEC filing (10-K/10-Q) against the prior same-form filing: paragraphs added and removed per section, with verbatim excerpts. Purely a deterministic text diff — no similarity scores, no directional read, not investment advice.
Comparing 10-Q · 2026-08-10 vs the prior 10-Q · 2026-05-11
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +25 | −13 | ~14 | 25 |
| Market risk (Item 3) | Text added/removed | 0 | 0 | ~1 | 0 |
| Controls & procedures | No paragraph-level changes | 0 | 0 | 0 | 3 |
| Legal proceedings | Text added/removed | +3 | −2 | ~3 | 8 |
| Risk factors | Some risk factors updated | +35 | −9 | ~1 | 2 |
| Other information | Text added/removed | 0 | 0 | ~2 | 0 |
Counts are paragraphs; added/removed means text added or removed vs the prior filing — no direction or judgement implied.
Representative excerpts
Up to 5 excerpts of about 300 characters per section, quoted verbatim from the two SEC filings.
MD&A
Text added vs the prior filing · source: 10-Q · 2026-08-10
On June 1, 2026, the U.S. District Court for the District of Delaware issued a decision in the patent litigation between the Company and Azurity Pharmaceuticals, Inc., Azurity Pharmaceuticals India LLP f/k/a Slayback Pharma India LLP, and Slayback Pharma LLC (“Azurity”), with respect to CINVANTI, ho…
On June 15, 2026, we submitted a notification to the FDA that SUSTOL will no longer be available for sale as of September 30, 2026. If we decide to recommence commercial marketing and sale of SUSTOL, we will notify the FDA before the anticipated launch date.
We, from time-to-time, are subject to claims and litigation in the normal course of the business. We may also incur costs related to maintaining, defending, and enforcing patent claims, including litigation costs and the outcome of such litigation. We have not reserved any amounts for contingencies …
Total acute care net product sales increased by $8.0 million or 38.2% during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The increase was primarily attributable to an increase in the units sold as a result of an increase in market share and new customers fo…
Total oncology net product sales decreased by $4.2 million or 15.9% during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The decrease was primarily attributed to a decrease in units sold as a result of continued competitive pressure.
Text removed vs the prior filing · source: 10-Q · 2026-05-11
lease commencement date, with the option to extend for one additional period of 84 months upon written notice. As the lease commencement date has not yet occurred, no right-of-use asset or lease liability has been recognized in the accompanying condensed consolidated financial statements. We provide…
Total oncology net product sales decreased by $7.5 million or 26.3% during the three months ended March 31, 2026, as compared to the comparable period in 2025. The decrease was primarily attributable to a decrease in units sold.
Cost of product sales increased by $2.2 million or 25.8% during the three months ended March 31, 2026, as compared to the comparable period in 2025 and as a percentage of sales increased 8.9% during the same period.
Gross profit for the three months ended March 31, 2026 was 69.4%, compared to 78.3% for the comparable period in 2025.
The increase in cost of product sales for the three months ended March 31, 2026, as compared to the same period in 2025, is primarily attributable to an increase of $0.3 million of inventory reserves and write-offs recorded and an increase of $1.9 million in the cost of units sold, primarily due to …
Legal proceedings
Text added vs the prior filing · source: 10-Q · 2026-08-10
On November 19, 2025, the Company received a Paragraph IV notice of certification (the “Baxter Notice”) from Baxter Healthcare Corporation (“Baxter”) advising that Baxter had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Baxter’s ANDA for a…
Noticed CINVANTI Patents, which are listed in the Orange Book. On December 23, 2025, the Company filed a complaint for patent infringement of the Noticed CINVANTI Patents against Baxter and a related entity in the U.S. District Court for the District of Delaware in response to the filing of Baxter’s…
On June 26, 2026, the Company received a Paragraph IV notice of certification (the “Long Grove Notice”) from Long Grove Pharmaceuticals, LLC (“Long Grove”) advising that Long Grove had submitted an application seeking approval to manufacture, use, or sell a generic version of CINVANTI in the U.S. (“…
Text removed vs the prior filing · source: 10-Q · 2026-05-11
On November 19, 2025, the Company received a Paragraph IV notice of certification (the “Baxter Notice”) from Baxter Healthcare Corporation (“Baxter”) advising that Baxter had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Baxter’s ANDA for a…
agreement with Baxter to resolve the ongoing patent litigation in the U.S. District Court for the District of Delaware related to Baxter’s ANDA for a generic version of CINVANTI. In connection with the settlement, on April 28, 2026, the Court granted the Stipulation and Order of Dismissal with the U…
Risk factors
Text added vs the prior filing · source: 10-Q · 2026-08-10
Our Products may face competition from lower-cost generic products offered by our competitors, which may limit our ability to sell our Products or require us to reduce our pricing.
Pricing for therapeutics can be extremely competitive, and strict formulary guidelines enforced by payors may create significant challenges in the acceptance and profitability of branded products. The market for generic products can be very lucrative, and it is dominated by companies that may have m…
We face competition from newly developed generic products as the Hatch-Waxman Act seeks to stimulate competition by providing incentives to generic pharmaceutical manufacturers to introduce non-infringing forms of patented pharmaceutical products and to challenge patents on branded pharmaceutical pr…
Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the “FDCA”). On June 1, 2026, the District Court issued a decision holding that the Company’s asserted claims of Azurity’s infringement of the ’255 Patent and the ’520 Patent are invalid under 35 U.S.C. § 112. The Court also entered a fi…
If the Company is unsuccessful in demonstrating infringement of its patents by an ANDA or 505(b)(2) product, or the validity of the Company’s patents is successfully challenged, lower-cost generic versions of our Products may be launched commercially and may compete with our Products, as they may be…
Text removed vs the prior filing · source: 10-Q · 2026-05-11
Changes in government policies, laws, and regulations and with respect to the government workforce may have a negative impact on our business and the markets in which we operate.
The laws and regulations governing our operations, as well as their interpretation, may change from time to time, and new laws and regulations may be enacted. Similarly, operational changes at government agencies, including actions intended to reduce government spending at agencies that regulate sig…
For example, the layoffs and reorganizations at several U.S. health agencies, including the FDA, the Department of Health and Human Services (the "HHS"), the Centers for Disease Control and Prevention and the National Institutes of Health, are expected to impact the FDA's ability to review and appro…
Accordingly, any change in these laws or regulations, changes in their interpretation, or newly enacted laws or regulations and any failure by us to comply with these laws or regulations could require changes to certain of our business practices, negatively impact our operations, cash flow or financ…
In addition, the U.S. Department of Commerce has initiated national security investigations into the importation of pharmaceuticals and pharmaceutical ingredients pursuant to Section 232 of the Trade Expansion Act of 1962, as amended (“Section 232”). Further, the U.S. announced a 100% tariff on any …
How to read Risk Factors (Item 1A) in a 10-Q
A 10-Q risk-factor section usually takes one of three forms; this page classifies it as one of:
- Pointer — the filer states there have been no material changes and points back to the annual 10-K risk factors; there is no own risk text to compare this quarter.
- Partial update — the filer carves out specific updated risks ("except as set forth below"); the excerpts show exactly what is new this quarter.
- Restated in full — the quarter carries the complete risk-factor text. When the prior quarter was only a pointer there is no prior full text to diff against, so the page flags the section as restated instead.
This describes the filing structure only — it is never a judgement on whether risk went up or down.
Source: text-level diff of the two SEC EDGAR filings · deterministic (no AI-generated content) · for reference only · not investment advice