On November 9, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will virtually participate in the following upcoming investor conferences (Press release, Jazz Pharmaceuticals, NOV 9, 2021, View Source [SID1234594909]):

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Jefferies London Healthcare Conference on Tuesday, November 16, 2021

The presentation is scheduled for 11:20 – 11:55 a.m. ET / 4:20 – 4:55 p.m. GMT
Evercore ISI HealthCONx Conference on Tuesday, November 30, 2021

The presentation is scheduled for 2:40 – 3:25 p.m. ET / 7:40 – 8:25 p.m. GMT
Jazz will virtually participate in both conferences and webcasts of the presentations will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharma.com. Replays of the webcasts will be available on the website for 30 days.

On November 9, 2021 Mirati Therapeutics, Inc. (Nasdaq: MRTX) a clinical-stage oncology company, reported that it intends to offer and sell in an underwritten public offering $500 million of shares of its common stock (Press release, Mirati, NOV 9, 2021, View Source [SID1234594908]). In addition, Mirati expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the total shares offered in the public offering at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Goldman Sachs & Co. LLC, SVB Leerink LLC and Cowen and Company, LLC are acting as joint book-running managers for the proposed offering.

The securities described above are being offered pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or from SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On November 9, 2021 Prenetics Group Limited ("Prenetics" or the "Company"), a global leader in genomic and diagnostic testing, reported its financial results for the six months ended June 30, 2021 (Press release, Prenetics, NOV 9, 2021, View Source [SID1234594907]). Prenetics delivered significant revenue growth, driven by continued demand across the world for its genomic and diagnostic testing services, including increased demand for COVID-19 testing as travel gradually resumes globally.

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The Company has publicly filed a registration statement on Form F-4 ("the Registration Statement") with the U.S. Securities and Exchange Commission ("SEC"), which contains a preliminary proxy statement/prospectus in connection with its previously announced proposed business combination with Artisan, a special purpose acquisition company founded by Adrian Cheng. The planned business combination continues to progress and is expected to close in the first quarter of 2022.

"We are pleased with our progress toward becoming a publicly-traded company, which we expect to occur in the first quarter of 2022. Prenetics again passed many milestones in the first half of 2021, growing revenue by 1,039% year on year, indicating a strong increase in demand for our testing services and the robustness of our technology. Going forward, we will continue to execute our growth strategy to put us amongst the fastest growing healthcare companies worldwide." said Danny Yeung, Group CEO & Co-founder of Prenetics.

He continued, "But I believe we are just getting started. We are at an inflection point within the healthcare ecosystem on how healthcare is to be delivered. Prenetics has a strong product pipeline and, as part of our global M&A strategy, we have already identified international targets in the area of rapid diagnostics and in digital health which would be highly complementary to our mission of decentralizing healthcare and bringing healthcare closer to millions of people globally."

Prenetics has a strong existing business and a robust product pipeline which include:

Circle HealthPod – Health Monitoring System providing rapid, lab-quality molecular testing for COVID-19 — anytime, anywhere. Circle HealthPod has received CE-IVD mark for point-of-care use. A usability study was completed in the U.S. and a clinical validation is in progress with aim to receive EUA from U.S. FDA by the first half of 2022. The Company has already begun developing assays to expand Circle HealthPod’s testing capacity to cover a range of tests traditionally conducted in clinical laboratories such as tests for influenza and STDs.

Circle ColoClear – Non-invasive stool-based FIT-DNA test for colorectal cancer screening. To be launched in the first half of 2022.

Circle SnapShot – At-home blood test with a user-friendly blood sample collection and result delivery system. To be launched in 2022.
Financial Highlights for the Six Months ended June 30, 2021

(1) For a reconciliation to the most directly comparable IFRS measure see the section titled "Unaudited Financial Information and Non-IFRS Financial Measures."

Revenue reached an all-time-high of US$136.5 million, an increase of 1,039% from US$12.0 million in the same period in 2020. This uplift was driven by increased demand for laboratory testing, including travel related COVID-19 testing.

For the six months ended June 30, 2021, Prenetics’ clients for its COVID-19 testing services include the Hong Kong government, Hong Kong International Airport, Multiple UK Airports, English Premier League and several global corporates including Virgin Atlantic, Carnival Cruise Line, and Sky TV.

Adjusted gross profit was US$57.0 million, an increase of 1,257%, from US$4.2 million in the same period in 2020, delivering a gross margin of 41.8%.

Adjusted EBITDA was US$31.5 million, increased by US$34.6 million year-over-year, due to increased operating efficiencies and scalability of the business.

As of June 30, 2021, the Company had cash and trade receivables of US$97.9 million, consisting of US$37.6 million of cash and US$60.3 million of trade receivables.
Recent Business Highlights

Prenetics announced on September 16, 2021 that it had entered into a definitive merger agreement with Artisan, a special purpose acquisition company privately founded by Adrian Cheng. The completion of the transaction is estimated to be by the first quarter of 2022. Upon completion of the transaction, the combined company ("PubCo")’s securities are expected to be traded on the Nasdaq under the ticker symbol "PRE".

Prenetics has now processed more than 6 million laboratory tests. On October 19, 2021, the Company announced that it was appointed as the official RT-PCR COVID-19 testing partner for the Standard Chartered Hong Kong Marathon 2021 that took place on October 24, 2021.

The Company continues to expand the utility and opportunity of next generation sequencing technologies in both consumer and clinical settings. In November 2021, the Company announced the addition of PacBio’s SMRT HiFi sequencing technology to its genetic screening services. PacBio’s technology will be a key component of Prenetics’ Circle Medical offering, a genetic test geared towards addressing the diagnostic needs of physicians and improving the accuracy of detecting mutations.

The Company has signed a strategic partnership agreement with EC Healthcare (stock code: 2138 Hong Kong), Hong Kong’s largest non-hospital medical group, to integrate all of Prenetics testing services as a service offering to EC Healthcare’s patients.

Prenetics has also made additions to its senior management team to support the company’s rapid growth. Yvonne Wong joined as the Chief Corporate Development Officer and is responsible for leading the company’s corporate development, ESG and CSR efforts. She has over 28 years of experience working in top-tier financial institutions and advising family offices and NGOs. CY Chan joined as the Chief People Officer and is responsible for leading the company’s people operations and culture strategy. He was formerly the CPO of HKBN Ltd. leading its HR and CSR functions.

Outlook

Based on its robust performance in the first half of 2021, Prenetics expects its revenue for 2021 to be ahead of its previous forecast of $205 million stated in the Investor Presentation of Artisan and Prenetics dated September 15, 2021. Whilst the Company is encouraged by the growth trajectory it has achieved, it maintains its projected annual revenues of more than US$600 million in 2025.

On November 9, 2021 Avalo Therapeutics, Inc. (Nasdaq: AVTX), a leading clinical-stage precision medicine company that discovers, develops, and commercializes targeted therapeutics for patients with significant unmet clinical need in immunology, immuno-oncology, and rare genetic diseases reported that business updates and third quarter 2021 financial results (Press release, Avalo Therapeutics, NOV 9, 2021, View Source [SID1234594906]).

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"The third quarter was focused on execution ahead of a number of data readouts in multiple key pipeline programs anticipated in the coming months," said Mike Cola, Chief Executive Officer of Avalo Therapeutics. "We further solidified our balance sheet with a successful public offering in September that puts the Company in a position to support the development of our pipeline through multiple catalysts."

Business Updates:

In July 2021, the Company reported positive initial results for the low-dose cohort (1.0 mg/kg) of its Phase 1b proof-of-concept study of AVTX-002, an investigational first-in-class fully human anti-LIGHT (tumor necrosis factor superfamily member 14 (TNFSF14)) monoclonal antibody (mAb), in adult patients with moderate to severe Crohn’s disease.
Completed rebranding to Avalo Therapeutics, Inc. from Cerecor Inc., accentuating the Company’s transition to developing innovative targeted therapies in immunology, immuno-oncology, and rare genetic diseases.
In September 2021, the Company raised gross proceeds of approximately $31.5 million through a public offering of common stock, which strengthens and extends the Company’s financial resources to advance its clinical pipeline towards key development milestones. Avalo had cash and cash equivalents of $71.5 million as of September 30, 2021.
During the third quarter of 2021, the Company completed its second drawdown of $10 million and third drawdown of $5 million under its previously announced $35 million venture debt financing agreement with Horizon Technology Finance Corporation. With the closing of the second and third tranches, the Company has received the full $35 million of gross proceeds under its debt financing agreement.
Program Updates and Milestones:

AVTX-002: Anti-LIGHT mAb targeting immune-inflammatory diseases including acute respiratory distress syndrome (ARDS) and moderate-to-severe inflammatory bowel disease (Crohn’s disease and ulcerative colitis).
The Company has completed enrollment in Cohort 2 (3.0 mg/kg) of its Phase 1b proof-of-concept trial of AVTX-002 in moderate-to-severe Crohn’s disease and anticipates top-line data in the fourth quarter of 2021.
Based on the positive data from Cohort 1 (1.0 mg/kg) of its Phase 1b trial of AVTX-002 in moderate-to-severe Crohn’s disease, the Company has expanded the IBD program to include patients with moderate-to-severe ulcerative colitis who are refractory to anti-TNF alpha therapies.
The Company remains in dialogue with the FDA and is working through feedback to determine the trial design for a registrational study of AVTX-002 in COVID-19 ARDS and accompanying timelines, including the potential expansion to a larger patient population in broader ARDS.
AVTX-007: Anti-IL-18 mAb targeting immuno-oncology and immune-inflammatory diseases including multiple myeloma (MM) and adult onset Still’s disease (AOSD).
The Company anticipates top-line data from the Phase 1b clinical trial in relapsed or refractory MM patients in the fourth quarter of 2021.
The Company anticipates initial data from the Phase 1b clinical trial in AOSD patients in the first quarter of 2022.

AVTX-006: Dual mTORc1/c2 small molecule inhibitor for complex lymphatic malformations.
The Company anticipates initial data from the Phase 1b proof-of-concept clinical trial in the first quarter of 2022.
AVTX-800 programs (AVTX-801, AVTX-802, and AVTX-803): Therapeutic doses of monosaccharide therapies for congenital disorders of glycosylation (CDGs).
AVTX-801 – In collaboration with the Frontiers in Congenital Disorders of Glycosylation Consortium clinical program, data from the pivotal trial evaluating the safety and efficacy of D-galactose in Phosphoglucomutase-1 deficiency related CDG (PGM1-CDG) patients are anticipated in 2022.
AVTX-802 – Data from the pivotal trial evaluating the safety and efficacy of D-mannose in Mannose phosphate isomerase deficiency related CDG (MPI-CDG) patients are anticipated in 2022.
AVTX-803 – Data from the pivotal trial evaluating the safety and efficacy of L-fucose in Leukocyte Adhesion Deficiency II (LAD II) patients are anticipated in the first half of 2022.
Third Quarter 2021 Financial Update:

As of September 30, 2021, Avalo had $71.5 million in cash and cash equivalents, representing a $52.6 million increase as compared to December 31, 2020. The increase was primarily driven by gross proceeds of $31.5 million from an underwritten public offering completed in September 2021, $35 million from a debt financing agreement entered into in June 2021 ($20 million funded in the second quarter and remaining $15 million funded in the third quarter), and gross proceeds of $40.7 million from an underwritten public offering completed in January 2021. Such increases were partially offset by operating expenditures, the majority of which related to pipeline development.

Net product revenue of the Company’s non-core commercialized product was $1.4 million for the three months ended September 30, 2021, which was largely consistent with the net product revenue for the three months ended September 30, 2020 of $1.1 million.

Total operating expenses increased $3.4 million for the three months ended September 30, 2021 as compared to the three months ended September 30, 2020, which was the largest driver of the increase in net loss period over period. The increased operating expenses were largely driven by a $1.7 million increase in research and development expenses due to Avalo’s continued advancement of its maturing pipeline.

Condensed Consolidated Balance Sheets

(a) The unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2021 and 2020 have been derived from the reviewed financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

On November 9, 2021 MannKind Corporation (Nasdaq: MNKD) reported financial results for the quarter and nine months ended September 30, 2021 (Press release, Mannkind, NOV 9, 2021, View Source [SID1234594905]).

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"The MannKind team continues to stay focused and execute our corporate objectives of preparing for the commercial launch of Tyvaso DPI, moving our pipeline forward and growing Afrezza," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "The recently completed animal toxicology studies of inhaled clofazimine support our timeline of moving this unique chemical entity into Phase 1 clinical trials by year-end."

Third Quarter 2021 Results
Total revenues were $22.2 million for the third quarter of 2021, an increase of $6.9 million or 45% from the same period in 2020, reflecting Afrezza net revenue of $9.8 million and collaboration and services revenue of $12.5 million. Afrezza net revenue increased $2.5 million, or 34%, compared to $7.3 million in the third quarter of 2020 as a result of higher prescription demand and price, including lower gross-to-net deductions. Collaboration and services revenue for the third quarter of 2021 increased $4.4 million, or 54%, compared to the third quarter of 2020 primarily due to additional development work associated with our collaboration with United Therapeutics ("UT").

Afrezza gross profit for the third quarter of 2021 was $5.9 million compared to $3.7 million in the same period of 2020, a 61% increase that was driven primarily by an increase in Afrezza net revenue. Gross margin in the third quarter of 2021 was 61% compared to 51% for the same period in 2020, reflecting the favorable impact of increased revenue.

Research and development ("R&D") expenses for the third quarter of 2021 were $3.7 million compared to $1.5 million for the third quarter of 2020. This increase of $2.2 million, or 146%, was attributable to research activities on our product pipeline and to the initiation of the Afrezza pediatrics clinical study (INHALE-1).

Selling, general and administrative ("SG&A") expenses for the third quarter of 2021 were $17.2 million compared to $13.9 million for the third quarter of 2020, an increase of $3.3 million, or 24%. The increase was primarily attributable to promotional expenses and patient support services of $2.0 million as well as personnel-related expenses of $2.6 million, which was driven by increased stock-based compensation and additional headcount to support Afrezza growth. The spending in SG&A in the third quarter of 2021 was partially offset by a reduction for the promotional cost for Thyquidity that was recognized as cost of revenue — collaboration and services in 2021.

For the third quarter of 2021, the gain on foreign currency translation for insulin purchase commitments denominated in Euros was $2.1 million compared to a loss of $3.9 million for the third quarter of 2020. The fluctuation was due to the change in the U.S. dollar to Euro foreign currency exchange rate.

Interest expense on debt for the third quarter of 2021 was $2.8 million compared to $2.4 million for the third quarter of 2020. This increase of $0.4 million was the result of interest on the $230.0 million 2.5% senior convertible notes issued in the first quarter of 2021, partially offset by a decrease in interest due to the repayment of $35.1 million of outstanding principal under the Mann Group non-convertible promissory note and the repayment of $10.0 million outstanding principal under the MidCap credit facility in the second quarter of 2021. In addition, we reduced the interest rates on the outstanding principal balances under the MidCap credit facility and the Mann Group convertible note through amendments to the respective agreements in the second quarter of 2021.

Gain on extinguishment of debt, a non-cash item, for the three months ended September 30, 2021 was $4.9 million as a result of the Small Business Association’s (the "SBA") forgiveness of our PPP loan in July 2021.

The net loss for the third quarter of 2021 was $4.4 million, or $0.02 per share, compared to $11.3 million in the third quarter of 2020, or $0.05 per share. The decreased net loss of $6.8 million was primarily due to an increase in Afrezza net revenues and revenues from collaboration and services, as well as a non-cash gain on the extinguishment of the PPP loan, partially offset by an increase in the cost of revenue from collaboration and services and of SG&A expenses. Non-GAAP net loss, adjusted to exclude the PPP loan debt extinguishment was $9.4 million, or $0.04 per share, for the three months ended September 30, 2021 compared to $11.3 million, or $0.05 per share, for the prior year period.

Nine Months September 30, 2021
Total revenues were $62.9 million for the nine months ended September 30, 2021, an increase of $16.2 million or 35% from the same period in 2020, reflecting Afrezza net revenue of $27.8 million and collaboration and services revenue of $35.1 million. Afrezza net revenue increased 25% compared to $22.3 million for the nine months ended September 30, 2020, as a result of higher prescription demand, the negative effects of the COVID-19 pandemic in the prior year period, a more favorable mix of Afrezza cartridges, and price including lower gross-to-net deductions. Collaboration and services revenue for the nine months ended September 30, 2021 increased $10.7 million, or 44%, compared to the nine months ended September 30, 2020, primarily due to additional development work associated with our collaboration with UT.

Afrezza gross profit for the nine months ended September 30, 2021 was $15.3 million compared to $10.8 million in the same period of 2020, a 41% increase that was driven primarily by an increase in Afrezza net revenue. Cost of goods sold increased $1.1 million compared to the same period in 2020, primarily due to a $2.0 million fee for an amendment of our insulin supply agreement and a $1.1 million decrease in manufacturing activities which resulted in a lower amount of costs capitalized to inventory, partially offset by $0.9 million of costs associated with lower manufacturing cost per unit and the termination of the free goods program in December 2020. Gross margin for the nine months ended September 30, 2021 was 55% compared to 49% for the same period in 2020. On a non-GAAP basis, which excludes the $2.0 million insulin supply amendment fee, gross margin was 62% for the nine months ended September 30, 2021 compared to 49% for the same period in 2020, reflecting the favorable impact of increased revenue.

R&D expenses for the nine months ended September 30, 2021 were $8.4 million compared to $4.7 million for the nine months ended September 30, 2020. This increase of $3.7 million, or 79%, was attributable to costs incurred for research activities on the product pipeline and to the initiation of the INHALE-1 study as well as personnel costs associated with additional headcount.

SG&A expenses for the nine months ended September 30, 2021 were $54.7 million compared to $41.9 million for the nine months ended September 30, 2020, an increase of $12.8 million, or 30%. The increase was primarily attributable to promotional expenses and patient support services of $5.8 million and personnel-related expenses of $8.5 million, which reflected increased stock-based compensation, additional headcount to support Afrezza growth and our voluntary reduction in compensation expense in response to the COVID-19 pandemic in the prior year. The spend in selling expenses was partially offset by a reduction related to the co-promotional cost for Thyquidity, which was recognized as cost of revenue – collaborations and services.

An impairment of $1.9 million was recognized for the nine months ended September 30, 2020 for a commitment asset related to the future funding commitments of the MidCap credit facility.

For the nine months ended September 30, 2021, the gain on foreign currency translation for insulin purchase commitments denominated in Euros was $5.0 million compared to a $4.0 million loss for the nine months ended September 30, 2020. The fluctuation was due to the change in the U.S. dollar to Euro foreign currency exchange rate.

Interest expense on debt for the nine months ended September 30, 2021 was $12.4 million compared to $7.1 million for the nine months ended September 30, 2020. This increase of $5.3 million was the result of a $3.7 million milestone obligation achieved in the first quarter of 2021 and interest on the $230.0 million 2.5% senior convertible notes issued in the first quarter of 2021, partially offset by a decrease in interest due to the repayment of $35.1 million of outstanding principal under the Mann Group non-convertible promissory note and the repayment of $10.0 million outstanding principal under the MidCap credit facility in the second quarter of 2021. In addition, we reduced the interest rates on the outstanding principal balances under the MidCap credit facility and the Mann Group convertible note through amendments to the respective agreements in the second quarter of 2021.

Non-cash net loss on extinguishment of debt of $17.2 million for the nine months ended September 30, 2021 consisted of a $22.1 million loss on extinguishment of debt for the amendment to the Mann Group convertible note, which did not result in a change in our financial position, partially offset by a $4.9 million gain on extinguishment of debt as a result of the SBA’s forgiveness of our PPP loan in July 2021.

The net loss for the nine months ended September 30, 2021 was $52.9 million, or $0.21 per share, compared to a $30.8 million net loss in the nine months ended September 30, 2020, or $0.14 per share. The increased net loss of $22.0 million was primarily due to the non-cash loss on extinguishment of the Mann Group convertible note of $22.1 million net of a non-cash gain on extinguishment of the PPP loan of $4.9 million, as well as an increase in SG&A expenses, cost of revenue – collaboration and services, partially offset by an increase in Afrezza net revenues and revenues from collaboration and services. Non-GAAP net loss as adjusted for the $17.2 million net loss on extinguishment of debt and the $2.0 million Amphastar amendment fee was $33.7 million, or $0.14 per share, for the nine months ended September 30, 2021 compared to $30.8 million, or $0.14 per share, for the same period in the prior year.

Cash, cash equivalents, and investments at September 30, 2021 were $181.1 million compared to $67.0 million at December 31, 2020. The increase in cash, cash equivalents and investments was primarily due to the issuance of $230.0 million of 2.5 % senior convertible notes in the first quarter of 2021.

Non-GAAP Measures
To supplement our unaudited condensed consolidated financial statements presented under U.S. generally accepted accounting principles (GAAP), we are presenting certain non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.

These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our unaudited condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

The following tables reconcile our gross margin financial measure to a non-GAAP presentation as adjusted for the nonrecurring amendment fee related to an amendment to our Insulin Supply Agreement.

The following tables reconcile our financial measure for net loss and EPS as reported in our condensed consolidated statement of operations to a non-GAAP presentation as adjusted for the $4.9 million non-cash gain on extinguishment of the PPP loan for the three months ended September 30, 2021 and the $22.1 million non-cash loss on extinguishment of the Mann Group convertible note and the $4.9 million gain on extinguishment of the PPP loan for the nine months ended September 30, 2021, which did not result in a change in our financial position, as well as the $2.0 million Amphastar amendment fee.

* Not meaningful
(1) There is no provision for income taxes associated with the non-cash net loss on extinguishment of debt or the Amphastar amendment fee as a result of our full valuation allowance.

Conference Call
MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at www.mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.