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SPRY on Nasdaq

Silverback Therapeutics

Logo: silverbacktx.com3

Biotech company based in Seattle, founded in 20161

In its 2026 annual report the company says: “We are a biopharmaceutical company focused on the commercialization and development of neffy (currently identified in the European Union and United Kingdom by the trade name EURneffy and in China by the trade name 优敏速 ) for needle-free intranasal delivery of epinephrine for emergency treatment of Type I allergic reactions, including anaphylaxis. neffy is the first and only FDA and European Commission-approved needle-free epinephrine product, and also has approvals in the U.K., Japan, Australia, and China.”5 Its shares trade on Nasdaq under the symbol SPRY.1

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Last updated Oct 21, 2026.

Overview

2016Founded1

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  • TickerSPRY on Nasdaq1
  • Industrybiotechnology industry1
  • HeadquartersSeattle1
  • Websitesilverbacktx.com
  • Incorporated inDE4
  • Business address11682 El Camino Real, Suite 300, San Diego, Ca 921304
  • Filer categoryNon-accelerated filer, Smaller reporting company4

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We are a biopharmaceutical company focused on the commercialization and development of neffy (currently identified in the European Union (“EU”) and United Kingdom (“U.K.”) by the trade name EURneffy and in China by the trade name 优敏速 ) for needle-free intranasal delivery of epinephrine for emergency treatment of Type I allergic reactions, including anaphylaxis. neffy is the first and only FDA and European Commission (“EC”)-approved needle-free epinephrine product, and also has approvals in the U.K., Japan, Australia, and China. It is the first new delivery method for epinephrine in more than 35 years. neffy is a proprietary composition of epinephrine with an innovative absorption enhancer called Intravail, which allows neffy to safely provide intranasal delivery of epinephrine at a low dose within the exposures of approved injectable products across a range of dosing conditions (includin…5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-212.9%Operating margin6
-203.3%Net margin6
-5.5%Revenue growth, 20256
-149.9%Return on equity6
0.84×Debt to equity6
-$171.2MFree cash flow6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product brought in 86% of the revenue Silverback Therapeutics broke down this way in fiscal 2025.

  1. Product$72.2M686%up 895% from 2024
  2. Revenue Under Collaboration Agreements$9.7M612%down 88% from 2024
  3. Revenue Under Supply Agreements$2.4M63%up 549% from 2024
Products and services by year
Products and services20242025
Product$7.3M$72.2M
Revenue Under Collaboration Agreements$81.5M$9.7M
Revenue Under Supply Agreements$365.0K$2.4M

Regions

United States brought in 86% of the revenue Silverback Therapeutics broke down this way in fiscal 2025.

  1. United States$72.2M686%up 895% from 2024
  2. Outside the United States$12.1M614%down 85% from 2024
Regions by year
Regions20242025
United States$7.3M$72.2M
Outside the United States$81.9M$12.1M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development5¢$13.2M
  • Selling, general and admin95¢$230.1M
  • Income tax0¢$80.0K

Out of $84.3M in revenue.6 The company lost money this year.

Financial statements

Revenue7896$84.3M in 2025+1431% since 2021
0$25.0M$50.0M$75.0M$100.0M2021: $5.5M$5.5M20212022: $1.3M$1.3M2022−76%2023: $30.0K$30.0K2023−98%2024: $89.1M$89.1M2024+297063%2025: $84.3M$84.3M2025−5%
Operating income107896-$179.4M in 2025+445% since 2020
-$200.0M-$150.0M-$100.0M-$50.0M02020: -$32.9M-$32.9M20202021: -$19.5M-$19.5M2021−41%2022: -$35.5M-$35.5M2022+83%2023: -$67.5M-$67.5M2023+90%2024: -$3.1M-$3.1M2024−95%2025: -$179.4M-$179.4M2025+5721%
Net income107896-$171.3M in 2025+420% since 2020
-$200.0M-$150.0M-$100.0M-$50.0M0$50.0M2020: -$32.9M-$32.9M20202021: -$20.2M-$20.2M2021−39%2022: -$34.7M-$34.7M2022+71%2023: -$54.4M-$54.4M2023+57%2024: $8.0M$8.0M20242025: -$171.3M-$171.3M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Total revenue$84.3M$89.1M
Cost of goods sold (including related party amounts of $4,781 and $241, respectively)$20.4M$977.0K
Selling, general and administrative (including related party amounts of $475 and $465, respectively)$230.1M$71.7M
Total operating expenses$263.7M$92.2M
Loss from operations-$179.4M-$3.1M
Interest income$10.7M$11.4M
Total other income, net$8.1M$11.4M
(Loss) income before income tax (benefit) expense-$171.4M$8.3M
Income tax (benefit) expense-$80.0K$288.0K
Net (loss) income-$171.3M$8.0M
Unrealized (losses) gains on available-for-sale securities-$95.0K$171.0K
Comprehensive (loss) income-$171.4M$8.2M
Net (loss) income per share, basic-$1.74$0.08
Net income (loss) per share, Diluted-$1.74$0.08
Weighted- average common shares outstanding, basic98.6M shares96.9M shares
Weighted Average Number of Shares Outstanding, Diluted98.6M shares102.4M shares
Research and development expenses related party amount$13.2M$19.6M
Interest expense related part amount$2.6M$0

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Corporate structure

Silverback Therapeutics sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Silverback Therapeutics

  • BlackRock Filed SCHEDULE 13G on Silverback Therapeutics, latest Jul 27, 2026 (3 filings since Jan 21, 2026)
  • MILLENNIUM MANAGEMENT LLC Filed SCHEDULE 13G/A on Silverback Therapeutics, latest Jul 14, 2026 (3 filings since Mar 24, 2026)
  • Rubric Capital Management LP Filed SCHEDULE 13G/A on Silverback Therapeutics, latest May 15, 2026 (2 filings since Feb 13, 2026)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13D/A on Silverback Therapeutics, latest Oct 1, 2025 (5 filings since Feb 14, 2022)
  • James E. Flynn Filed SCHEDULE 13D/A on Silverback Therapeutics, latest Aug 1, 2025 (5 filings since Nov 18, 2022)
  • Pratik Shah Living Trust dated June 15, 2011 Filed SC 13D/A on Silverback Therapeutics, latest Jun 17, 2024 (3 filings since Nov 18, 2022)
  • FMR LLC Filed SC 13G/A on Silverback Therapeutics, latest Feb 9, 2024 (3 filings since Feb 9, 2022)
  • Robert G. Bell Filed SC 13D/A on Silverback Therapeutics, latest Sep 1, 2023 (2 filings since Nov 21, 2022)
  • Vi Oncology Scsp Nextech Filed SC 13G/A on Silverback Therapeutics, latest Feb 14, 2023
  • K2 PRINCIPAL FUND, L.P. Filed SC 13G/A on Silverback Therapeutics, latest Feb 13, 2023 (2 filings since Jul 18, 2022)
  • ORBIMED ADVISORS LLC Filed SC 13D/A on Silverback Therapeutics, latest Nov 30, 2022
  • Richard E. Lowenthal Filed SC 13D on Silverback Therapeutics, latest Nov 18, 2022
  • Silverback Therapeutics Seattle

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Silverback Therapeutics reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Accumulated depreciation$200.0K9 Dec 31, 2024$121.0K9 Dec 31, 2023+65.3%
Property and equipment, net$2.5M6 Dec 31, 2025$1.1M6 Dec 31, 2024+131.2%
Operating-lease assets (leased space)$37.0K9 Dec 31, 2024$250.0K9 Dec 31, 2023−85.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$41.3M6 Dec 31, 2025$50.8M6 Dec 31, 2024−18.7%
Marketable securities, current$203.7M6 Dec 31, 2025$263.2M6 Dec 31, 2024−22.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$14.5M6 Dec 31, 2025$7.4M6 Dec 31, 2024+96.1%
Accumulated amortization$908.0K6 Dec 31, 2025$129.0K6 Dec 31, 2024+603.9%
Finite-lived intangibles, net$5.5M6 Dec 31, 2025$2.6M9 Dec 31, 2024+113.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$31.4M6 Dec 31, 2025$10.5M6 Dec 31, 2024+198.7%
Raw materials$26.8M6 Dec 31, 2025$4.7M6 Dec 31, 2024+473.7%
Work in process$288.0K6 Dec 31, 2025$19.0K6 Dec 31, 2024+1415.8%
Finished goods$4.3M6 Dec 31, 2025$5.8M6 Dec 31, 2024−25.9%

Properties, in its own words

Our corporate headquarters are located in San Diego, California, where we lease approximately 9,254 square feet of office space. We believe that our facilities are adequate for our current needs.

Item 2 of the 10-K filed Mar 9, 2026.5

Leadership

Who has led Silverback Therapeutics, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Laura Shawver2020–2022
  2. Jeffrey C. Pepe2022
  3. Richard E. Lowenthal2022–now

President

  1. Valerie Odegard2020–2022
  2. Richard E. Lowenthal2022–2026
  3. Donn Casale2026–now

Chief financial officer

  1. Jonathan Piazza2020–2022
  2. Kathleen D. Scott2022–now

Chief operating officer

  1. Brian Dorsey2022–now
20202025
Board members and other officers (25)

Former names

  • Silverback Therapeutics, Inc.Apr 12, 2016 to Nov 8, 20224

Timeline

  1. Aug 13, 20268-K Results of operations42
  2. Jul 17, 20268-K Executive or director change43
  3. Jul 7, 20268-K Executive or director change44
  4. Jun 25, 20268-K Shareholder vote45
  5. May 15, 20268-K Results of operations; Regulation FD disclosure46
  6. May 13, 20268-K Executive or director change47
  7. Mar 9, 20268-K Results of operations; Regulation FD disclosure48
  8. Nov 10, 20258-K Results of operations; Regulation FD disclosure49
  9. Sep 29, 20258-K Entered a material agreement; New debt or obligation50
  10. Aug 28, 20258-K Other events51
  11. Aug 13, 20258-K Results of operations; Regulation FD disclosure52
  12. Jun 26, 20258-K Shareholder vote53
  13. Nov 10, 2022New chief executive Richard E. Lowenthal becomes CEO14
  14. Sep 8, 2022New chief executive Jeffrey C. Pepe becomes CEO13
  15. Dec 3, 2020New chief executive Laura Shawver becomes CEO15
  16. 2016Founded Founded1

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.52) a share, on Nov 10, 2025.54

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results42
  2. May 15, 2026Reported quarterly or annual results46
  3. Mar 9, 2026Reported quarterly or annual results48
  4. Nov 10, 2025Reported quarterly or annual results49
  5. Aug 13, 2025Reported quarterly or annual results52
  6. May 14, 2025Reported quarterly or annual results55
  7. Mar 20, 2025Reported quarterly or annual results56
  8. Jan 13, 2025Reported quarterly or annual results57

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

447 filings to the SEC since October 2021: 5 annual reports, 16 quarterly reports, 58 major events, 223 insider forms, 36 large holders, 109 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Oct 1, 2026144 EDGAR
  3. Sep 30, 2026144 EDGAR
  4. Sep 11, 2026144 EDGAR
  5. Sep 11, 2026144 EDGAR
  6. Sep 4, 2026144 EDGAR
  7. Sep 3, 2026144 EDGAR
  8. Sep 2, 20264 EDGAR
  9. Sep 2, 2026144 EDGAR
  10. Sep 1, 2026144 EDGAR
  11. Aug 31, 2026144 EDGAR
  12. Aug 20, 2026144 EDGAR
  13. Aug 20, 2026144 EDGAR
  14. Aug 19, 2026144 EDGAR
  15. Aug 19, 2026144 EDGAR
  16. Aug 18, 2026144 EDGAR
  17. Aug 18, 2026144 EDGAR
  18. Aug 17, 20263 EDGAR
  19. Aug 13, 202610-Q EDGAR
  20. Aug 13, 20268-K EDGAR

The 447 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

139 open-market trades by officers, directors and large owners since October 2021: 11 buys and 128 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 12, 2026Karas EricChief Commercial OfficerSale25,000$10.00$250.0KForm 4
Jun 12, 2026Fitzpatrick Alexander AChief Legal OfficerSale3,355$10.00$33.5KForm 4
Nov 13, 2025Dorsey BrianChief Operating OfficerSale21,828$8.71$190.1KForm 4
Nov 12, 2025Chakma JustinChief Business OfficerSale166,380$8.87$1.5MForm 4
Aug 21, 2025Lowenthal Richard EPRESIDENT AND CEOSale50,000$14.49$724.5KForm 4
Aug 21, 2025Scott Kathleen D.Chief Financial OfficerSale12,500$15.00$187.5KForm 4
Aug 20, 2025Tanimoto SarinaCHIEF MEDICAL OFFICERSale37,656$14.09$530.6KForm 4
Aug 19, 2025Tanimoto SarinaCHIEF MEDICAL OFFICERSale12,344$14.03$173.2KForm 4
Jul 1, 2025Karas EricChief Commercial OfficerSale15,000$16.99$254.8KForm 4
Jun 27, 2025Flynn James E10% ownerSale740,149$18.46$13.7MForm 4
Jun 18, 2025Karas EricChief Commercial OfficerSale15,000$16.00$240.0KForm 4
May 20, 2025Fitzpatrick Alexander AChief Legal OfficerSale102,969$14.10$1.5MForm 4
May 20, 2025SAUNDERS BRENT LDirectorSale120,000$14.25$1.7MForm 4
May 20, 2025Scott Kathleen D.Chief Financial OfficerSale50,000$14.10$705.0KForm 4
Apr 7, 2025Shawver LauraDirectorSale50,002$12.30$615.0KForm 4
Mar 20, 2025Karas EricChief Commercial OfficerSale10,000$14.00$140.0KForm 4
Mar 6, 2025Shawver LauraDirectorSale49,600$11.21$556.0KForm 4
Mar 5, 2025Shawver LauraDirectorSale400$11.00$4.4KForm 4
Feb 3, 2025Shawver LauraDirectorSale50,000$12.31$615.5KForm 4
Jan 6, 2025Shawver LauraDirectorSale50,000$11.10$555.0KForm 4

All 139 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Richard LowenthalM.S., MSEL$700.0K$9.7M75
2025Sarina TanimotoM.D., M.B.A.$540.0K$5.3M75
2025Justin Chakma$497.0K$2.9M75
2024President and Chief Executive Officer$651.0K$7.2M75
2024Chief Medical Officer$501.7K$4.2M75

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Ra Capital Management, L.P.10,860,977$87.0M0.8%No change
Rubric Capital Management LP8,540,861$68.4M0.6%+540,861
Orbimed Advisors LLC8,288,510$66.4M1.3%No change
Deerfield Management Company, L.P.7,503,812$60.1M0.7%No change
BlackRock, Inc.5,311,319$42.5M0.0%+299,065
Tyro Capital Management LLC4,459,337$35.7M8.0%+1,490,738
Aberdeen Group plc4,170,629$33.4M0.0%+57,012
SR One Capital Management, LP4,012,903$32.1M3.1%No change
State Street Corp3,730,623$29.9M0.0%+85,657
Capital World Investors2,754,931$22.1M0.0%New
Vanguard Capital Management LLC2,553,528$20.5M0.0%+11,024
Millennium Management LLC2,400,937$19.2M0.0%−3,581,982
UBS Group AG1,939,654$15.5M0.0%−320,671
Geode Capital Management, LLC1,699,017$13.6M0.0%+172,193
Boothbay Fund Management, LLC1,601,504$12.8M0.2%+1,350,907
General American Investors Co Inc1,133,046$9.1M0.6%+405,892
Third Point LLC1,000,000$8.0M0.2%No change
Peregrine Capital Management LLC672,139$5.4M0.2%New
Tejara Capital Ltd607,039$4.9M2.0%+396,639
ADAR1 Capital Management, LLC600,999$4.8M0.2%−760,537
Pavaki Capital Management LLC579,600$4.6M2.6%+3,400
Vanguard Portfolio Management LLC566,829$4.5M0.0%+56,278
Charles Schwab Investment Management Inc551,416$4.4M0.0%+18,022
Northern Trust Corp549,064$4.4M0.0%+19,780
Levin Capital Strategies, L.P.548,965$4.4M0.3%−3,596

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Silverback Therapeutics is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARARS Pharmaceuticals, Inc.2
  • CIK0001671858
  • Employer ID (EIN)81-14891905
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address11682 El Camino Real, Suite 300, San Diego, CA 921302
  • Phone858-771-93072
  • Shares outstanding99,447,343 as of Aug 11, 202612
  • Public float$1.1B as of Jun 30, 20255
  • AuditorErnst & Young LLP, San Diego, California PCAOB ID 42; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceApr 12, 20162
  • Filings543 in all: 4 (230), 8-K (66), 144 (65), 3 (34), 10-Q (17), DEFA14A (11), SC 13G/A (10), CORRESP (9)2
    All 40 form types

    SC 13D (9), UPLOAD (8), D (7), S-8 (7), SC 13G (7), 10-K (6), DEF 14A (6), SC 13D/A (6), SCHEDULE 13D/A (5), ARS (4), SCHEDULE 13G (4), SCHEDULE 13G/A (4), EFFECT (3), 144/A (2), 3/A (2), 4/A (2), S-1/A (2), S-3 (2), SEC STAFF LETTER (2), 10-Q/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), D/A (1), DEFM14A (1), DRS (1), PREM14A (1), PRER14A (1), S-1 (1), S-1MEF (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Aug 13, 2026

Securities registered for trading

ClassSymbolExchange
Common StockSPRYThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Silverback Therapeutics names in Item 1A of its 10-K filed Mar 9, 2026: 72 risks under these headings, as written.5

  • Risks Related to Our Business
  • We are highly dependent on the successful commercialization of neffy. To the extent neffy and EURneffy are not commercially successful, our business, financial condition and results of operations would be materially adversely affected, and the price of our common stock would likely decline.
  • If we are unable to fully develop and maintain our sales, marketing and distribution capabilities on our own or through collaborations with marketing partners, we may not be successful in commercializing neffy.
  • neffy and our current and future intranasal epinephrine technology product candidates may fail to achieve the degree of market acceptance by allergists, pediatricians and other physicians, patients, caregivers, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or profits.
  • The market for neffy and our intranasal epinephrine technology may be smaller than we expect.
  • If we are unable to achieve and maintain adequate levels of third-party payor coverage and reimbursement for neffy on reasonable pricing terms, its commercial success may be severely hindered.
  • neffy has only been studied in a limited number of patients. neffy is now available to a much larger number of patients, and we do not know whether the results of neffy’s use in such larger number of patients will be consistent with the results from our clinical studies.
  • Competitive products may reduce or eliminate the commercial opportunity for neffy or our current and future intranasal epinephrine technology product candidates. If our competitors develop technologies or product candidates more rapidly than us, or their technologies or product candidates are more effective or safer than ours, our ability to develop and successfully commercialize neffy and our current and future intranasal epinephrine technology product candidates may be adversely affected.
  • If the FDA, the European Commission or other comparable foreign regulatory authorities approve generic versions of neffy or our current or future intranasal epinephrine technology product candidates that receives regulatory approval, or such authorities do not grant our products appropriate periods of non-patent exclusivity before approving generic versions of such products, the sales of such products could be adversely affected.
  • Obtaining regulatory approval of neffy or our current or future intranasal epinephrine technology product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval in other jurisdictions.
  • If we are unable to successfully develop our current or future intranasal epinephrine technology product candidates, or neffy for additional indications, or experience significant delays in doing so, the commercial potential of our current or future intranasal epinephrine technology product candidates or neffy will be more limited.
  • We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, further development and the commercialization of our current and future intranasal epinephrine technology product candidates.
The other 61 risks
  • We may not be successful in our efforts to expand our pipeline by identifying additional indications for which to investigate intranasal epinephrine technology in the future or by developing or acquiring new products or product candidates. We may expend our limited resources to pursue a particular indication or formulation for our intranasal epinephrine technology and fail to capitalize on product candidates, indications or formulations that may be more profitable or for which there is a greater likelihood of success.
  • The results of early-stage clinical trials and preclinical studies may not be predictive of future results. Initial data in our clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials.
  • Interim topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • neffy or our current or future intranasal epinephrine technology product candidates may cause undesirable side effects, adverse events, or have other properties that could delay or prevent its regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following regulatory approval, if obtained.
  • We may seek priority review by the FDA for potential additional indications, including urticaria, for our current or future intranasal epinephrine technology product candidates, and we may be unsuccessful. If we are successful, the designation may not actually lead to a faster development or regulatory review or approval process.
  • Product liability lawsuits against us or any of our current and future licensing and collaboration partners could divert our resources and attention, cause us to incur substantial liabilities and limit commercialization of neffy or our current or future intranasal epinephrine technology product candidates.
  • If our information technology systems or data, or those of third parties with whom we work, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • A pandemic, epidemic, or outbreak of an infectious disease may materially and adversely affect our business, including our nonclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results.
  • The FDA and other regulatory agencies actively enforce the laws and regulations relating to the promotion of our products.
  • The increasing use of social media platforms presents new risks and challenges.
  • Risks Related to Our Results of Operations and Financial Position
  • We expect that our timing of sales and our results of operations will fluctuate for the foreseeable future, which may make it difficult to predict our future performance from period to period.
  • We have incurred significant losses since our inception.
  • We may need additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development activities or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidate.
  • Our Credit Agreement contains conditions and restrictions that limit our flexibility in drawing on the additional funds thereunder and in operating our business. We may be required to repay our outstanding indebtedness under the Credit Agreement earlier than we expect and possibly at a time when we do not have sufficient capital to meet such obligations if an event of default occurs (including a material adverse change affecting our business), which could have a material adverse effect on our financial condition and results of operations.
  • Changes in tax law could adversely affect our business and financial condition.
  • Our ability to use net operating loss carryforwards and certain other tax attributes may be limited.
  • Risks Related to our Legal and Regulatory Environment
  • Recently enacted and future legislation may increase the difficulty and cost for us to commercialize neffy or our current or future intranasal epinephrine technology product candidates and affect the prices we may obtain.
  • Disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business relies.
  • Governments outside the United States may impose strict price controls, which may adversely affect our revenues, if any.
  • Our business activities may be subject to the FCPA and similar anti-bribery and anti-corruption laws of other countries in which we may operate, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • Our relationships with customers, health care professionals and third-party payors may be subject to applicable healthcare laws, which could expose us to penalties, including administrative, civil or criminal penalties, damages, fines, imprisonment, exclusion from participation in federal healthcare programs such as Medicare and Medicaid, reputational harm, the curtailment or restructuring of our operations and diminished future profits and earnings.
  • We will incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
  • Risks Related to Our Dependence on Third Parties
  • We rely completely on third parties to manufacture and warehouse both our domestic and international supply of neffy and our current and future intranasal epinephrine technology product candidates.
  • We are dependent on international third-party licensees and assignees for the development and commercialization of neffy and our current and future intranasal epinephrine technology product candidates outside the United States. If these third parties are not successful in their development and commercialization efforts or if these third parties fail to meet their contractual, regulatory or other obligations, our business and results of operations could be adversely affected.
  • neffy and our current or future intranasal epinephrine technology product candidates are developed and produced at a few locations, and a business interruption at one or more of these locations or within our supply chain could have a material adverse effect on our business, financial position, and results of operations.
  • We rely on third parties to conduct our nonclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, our development programs and our ability to commercialize neffy and our current or future intranasal epinephrine technology product candidates may be delayed.
  • Our reliance on third parties requires us to share our trade secrets, know-how and other proprietary information, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks Related to Our Intellectual Property
  • Our commercial success depends on our ability to obtain and maintain sufficient intellectual property protection for neffy, our current and future intranasal epinephrine technology product candidates and other proprietary technologies.
  • If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
  • We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
  • Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect neffy and our current or future intranasal epinephrine technology product candidates.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Patent terms may be inadequate to protect our competitive position for neffy and our current or future intranasal epinephrine technology product candidates for an adequate amount of time and may adversely affect our anticipated future revenues and operating earnings.
  • We cannot ensure that patent rights relating to inventions described and claimed in our pending patent applications will issue or that patents based on our patent applications will not be challenged and rendered invalid and/or unenforceable.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market neffy and our current or future intranasal epinephrine technology product candidates.
  • If we are sued for infringing on the intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing neffy or our current or future intranasal epinephrine technology product candidates.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful and could result in a court or administrative body finding our patents to be invalid or unenforceable.
  • neffy or our current or future intranasal epinephrine technology product candidates may face competition from generic intranasal epinephrine products sooner than expected, and our patents may be challenged.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation.
  • We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • In the future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated.
  • Risks Related to Employee Matters and Managing Growth
  • Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.
  • Our employees, independent contractors, consultants, current and future licensing and collaboration partners and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
  • We may encounter difficulties in managing our growth, which could disrupt our operations.
  • Risks Related to the Securities Markets and Ownership of Our Common Stock
  • The market price of our common stock could be volatile.
  • Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock.
  • Our amended and restated certificate of incorporation designates the state courts of the State of Delaware or, if no state court located within the State of Delaware has jurisdiction, the federal court for the District of Delaware, and the federal district courts of the United States of America to be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers and employees.
  • We do not anticipate paying any cash dividends in the foreseeable future.
  • Future sales of shares by existing stockholders could cause our stock price to decline.
  • General Risk Factors
  • Geo-political conditions may have serious adverse consequences on our business, financial condition and stock price.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.

Legal proceedings

From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. See Note 10 - Commitments and Contingencies of this Annual Report, which is incorporated by reference in this Item 3, for any required disclosure.

The opening of Item 3, Legal Proceedings.5

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