On November 4, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the third quarter of 2021 and provided a business update (Press release, Regeneron, NOV 4, 2021, View Source [SID1234594449]).

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"Regeneron had another strong quarter of core business growth, with EYLEA and Dupixent reaching more patients than ever and progress made across our diverse pipeline," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We secured a new U.S. government supply agreement and are delivering an additional 1.4 million doses of REGEN-COV. Our Biologics License Application for REGEN-COV as treatment and prophylaxis was accepted by the FDA for priority review, with a mid-April 2022 action date. During the third quarter, we announced positive data from Phase 3 trials of Dupixent in chronic spontaneous urticaria and pediatric atopic dermatitis. We also recently announced positive data from Phase 3 trials of Dupixent in eosinophilic esophagitis and prurigo nodularis, and that the FDA approval in pediatric asthma was extended to children as young as six. Finally, our abstracts that will be released today for the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting highlight programs across the hematology portfolio, including our BCMA and C5 antibodies."

"Regeneron performed extremely well in the third quarter with strong top- and bottom-line growth driven by an increasingly diversified core business," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "We are approaching the end of 2021 with positive momentum as we continue to invest in our broad pipeline to drive sustained long-term growth."

Business Highlights

Key Pipeline Progress
Regeneron has over 30 product candidates in clinical development, including six marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

EYLEA (aflibercept) Injection

In August 2021, the Company announced that an ongoing Phase 2 trial evaluating an 8 mg dose of aflibercept in patients with neovascular age-related macular degeneration (wet AMD) met its primary safety and efficacy endpoints. The high-dose aflibercept formulation is currently also being evaluated in two large Phase 3 trials in wet AMD and diabetic macular edema (DME), which are expected to report results in the second half of 2022.
Dupixent (dupilumab)

In October 2021, the U.S. Food and Drug Administration (FDA) approved Dupixent for children aged 6 to 11 years with moderate-to-severe asthma.
In July 2021, the Company and Sanofi announced that a Phase 3 trial in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints at 24 weeks.
In October 2021, the Company and Sanofi announced that a second Phase 3 trial in adults and adolescents with eosinophilic esophagitis (EoE) met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo. A rolling supplemental Biologics License Application (sBLA) has been initiated for adults and adolescents with EoE.
In October 2021, the Company and Sanofi announced that a Phase 3 trial in adults with uncontrolled prurigo nodularis met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting. Results from an additional Phase 3 trial in prurigo nodularis are expected to be reported in the first half of 2022.
In August 2021, the Company and Sanofi announced that a Phase 3 trial in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis met its primary and all secondary endpoints, and the companies expect to complete regulatory submissions in the United States and European Union (EU) in the coming months.
REGEN-COV (casirivimab and imdevimab)(2), a dual antibody cocktail to SARS-CoV-2 virus

In September 2021, the Company announced an agreement to supply the U.S. government with an additional 1.4 million doses of REGEN-COV (of which over 300,000 doses were delivered during the third quarter of 2021). Pursuant to the agreement, the U.S. government is obligated to purchase REGEN-COV doses delivered by January 31, 2022, resulting in aggregate payments to the Company of up to $2.940 billion. Roche will supply a portion of the doses to Regeneron to fulfill Regeneron’s agreement with the U.S. government.
The FDA accepted for priority review the BLA for COVID-19 treatment in non-hospitalized patients and as prophylaxis in certain individuals, with a target action date of April 13, 2022. A Marketing Authorization Application (MAA) for COVID-19 treatment in infected non-hospitalized patients or as prophylaxis was also submitted in the EU.
In September 2021, the Company announced that a Phase 3 trial in patients hospitalized with COVID-19 met its primary endpoint, showing REGEN-COV significantly reduced viral load. The FDA is currently reviewing the Company’s request to expand the Emergency Use Authorization (EUA) to include treatment in hospital settings, and the Company plans to submit a BLA and MAA for this patient population in the coming months.
The New England Journal of Medicine published positive detailed results from the Phase 3 trial that assessed the ability of REGEN-COV to treat COVID-19 in infected high-risk non-hospitalized patients.
Oncology Programs

The FDA accepted for priority review, with a target action date of January 30, 2022, the sBLA for Libtayo (cemiplimab) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. The MAA in the EU is expected to be submitted by the end of the year.
Positive data from the Phase 3 trial of Libtayo, in combination with chemotherapy, in patients with advanced non-small cell lung cancer, were presented at the European Society for Medical Oncology Virtual Congress 2021. These results will form the basis of regulatory submissions, which are planned in the United States and EU in the coming months.
A Phase 1 study of REGN5093-M114, a bispecific antibody-drug conjugate targeting two distinct MET epitopes, was initiated in MET-altered advanced non-small cell lung cancer.
Pozelimab, an antibody to C5

A Phase 3 study of pozelimab in combination with cemdisiran, a siRNA therapeutic, in myasthenia gravis was initiated.
REGN5713-5714-5715, a multi-antibody therapy to Bet v 1

The initial Phase 3 study in birch allergic patients with allergic rhinoconjunctivitis met its primary endpoint with a reduction in the combined allergic rhinitis symptom and medication score. The Company is currently evaluating further development plans, including an additional Phase 3 study during an upcoming birch pollen season.
Third Quarter 2021 Financial Results

Revenues

Total revenues increased by 51% to $3.453 billion in the third quarter of 2021, compared to $2.294 billion in the third quarter of 2020. Total revenues excluding (i) REGEN-COV (casirivimab and imdevimab) net product sales in the United States and (ii) the Company’s share of gross profits in connection with sales of casirivimab and imdevimab pursuant to the Roche collaboration agreement, increased by 18% to $2.649 billion in the third quarter of 2021, compared to the third quarter of 2020(1).

Net product sales recorded by the Company consist of the following:

During the third quarter of 2021, the Company commenced deliveries of REGEN-COV under its September 2021 supply agreement with the U.S. government (as described above).

Total revenues also include collaboration revenues(3) of $1.074 billion in the third quarter of 2021, compared to $653 million in the third quarter of 2020. Sanofi collaboration revenue increased primarily due to the Company’s share of profits from commercialization of antibodies, which were $387 million in the third quarter of 2021, compared to $213 million in the third quarter of 2020. The change in the Company’s share of profits from commercialization of antibodies was driven by higher Dupixent profits. In addition, in both the third quarter of 2021 and 2020, the Company earned $50 million sales-based milestones from Sanofi based upon sales of antibodies outside the United States on a rolling twelve-month basis. In the third quarter of 2021, the Company also recorded Roche collaboration revenue of $127 million in connection with the true-up payment owed from Roche in connection with global gross profits from sales of the casirivimab and imdevimab antibody cocktail.

Refer to Table 4 for a summary of collaboration revenue.

Other revenue decreased in the third quarter of 2021, compared to the third quarter of 2020, primarily due to lower amounts recognized in connection with the Company’s agreements with the Biomedical Advanced Research Development Authority (BARDA) related to funding of certain development activities for COVID-19 antibodies, and, to a lesser extent, Inmazeb.

The increase in SG&A expenses in the third quarter of 2021 was primarily due to higher headcount-related costs and an increase in commercialization-related expenses for EYLEA, including direct-to-consumer advertising.
The increase in COGS in the third quarter of 2021 was primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV in the United States.
The increase in COCM in the third quarter of 2021 was primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent.
Other operating expense (income), net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with the Company’s collaborative arrangements. The decrease in other operating income in the third quarter of 2021 was primarily due to the recognition of a cumulative catch-up adjustment of $67 million arising from an update to the estimate of the total R&D costs expected to be incurred under the Sanofi Immuno-oncology collaboration agreement.
Other Financial Information

In the third quarter of 2021, the Company’s GAAP effective tax rate was 10.2%, compared to 15.6% in the third quarter of 2020. The decrease in the third quarter 2021 GAAP effective tax rate, compared to the third quarter of 2020, was due in part to the positive impact of stock-based compensation in the third quarter of 2021. In the third quarter of 2021, the non-GAAP effective tax rate was 10.8%, compared to 16.3% in the third quarter of 2020.

GAAP net income per diluted share was $14.33 in the third quarter of 2021, compared to GAAP net income per diluted share of $7.39 in the third quarter of 2020. Non-GAAP net income per diluted share was $15.37 in the third quarter of 2021, compared to non-GAAP net income per diluted share of $8.36 in the third quarter of 2020. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

Net cash provided by operating activities in the first nine months of 2021 was $4.709 billion, compared to $1.387 billion in the first nine months of 2020, resulting in $4.312 billion in free cash flow(1) for the first nine months of 2021, compared to $934 million for the first nine months of 2020. The increase in free cash flow was primarily due to the Company’s collection of amounts due from the U.S. government in connection with REGEN-COV sales in 2021.

2021 Financial Guidance(4)

The Company’s full year 2021 financial guidance consists of the following components:

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its third quarter 2021 financial and operating results on Thursday, November 4, 2021, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast on the "Investors and Media" page of Regeneron’s website at www.regeneron.com. To participate via telephone, please register in advance at View Source Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On November 4, 2021 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the third quarter ended September 30, 2021 and provided pipeline updates (Press release, AnaptysBio, NOV 4, 2021, View Source [SID1234594448]).

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"Our wholly-owned pipeline continues to make progress with the recent initiation of our imsidolimab GEMINI-1 Phase 3 trial in GPP and anticipated initiation of our rosnilimab AZURE alopecia areata Phase 2 trial during the remainder of 2021," said Hamza Suria, president and chief executive officer of AnaptysBio. "We believe the recent royalty monetization transaction with Sagard validates the future revenue stream anticipated from JEMPERLI sales and further supports AnaptysBio’s capital-efficient business model."

Imsidolimab (Anti-IL-36 Receptor) Program

Following an end-of-Phase 2 meeting with the FDA in Q2 2021, we publicly disclosed Phase 3 trial designs for imsidolimab in generalized pustular psoriasis (GPP), GEMINI-1 and GEMINI-2. The primary endpoint of our GEMINI-1 Phase 3 trial is the proportion of patients achieving a score of clear (0) or almost clear (1) skin on the Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) at week 4 in 45 patients randomized against placebo. GEMINI-2 will assess 6 months of monthly subcutaneous dosing and safety follow-up of those same patients. GEMINI-1 was initiated in Q3 2021.
Full data from the Phase 2 GALLOP trial in GPP, including efficacy and safety of imsidolimab treatment through week 16, was disclosed in an oral presentation by Dr. Johann Gudjonsson, professor of Dermatology at the University of Michigan, at the European Academy of Dermatology and Venereology (EADV) Congress on October 2nd, 2021. Imsidolimab demonstrated rapid and sustained efficacy with 6 of 8 (75%) GPP patients achieving the primary endpoint at week 4 and 16. We also observed early reduction of erythema with pustules by 60% at week 1, 94% reduction at week 4, 98% reduction at week 16, each versus baseline.
We anticipate top-line data from the ACORN Phase 2 trial of imsidolimab in moderate-to-severe acne in H1 2022 and from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa in H2 2022.
Rosnilimab (Anti-PD-1 Agonist) Program

We anticipate top-line data in Q4 2021 from our ongoing Phase 1 healthy volunteer trial of rosnilimab, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of rosnilimab in single and multiple ascending dose cohorts.
We plan to initiate a randomized, placebo-controlled Phase 2 clinical trial of rosnilimab in alopecia areata in Q4 2021.
ANB032 (Anti-BTLA Modulator) Program

We are advancing ANB032, our wholly-owned BTLA modulator antibody, in a healthy volunteer Phase 1 single and multiple ascending dose clinical trial where top-line data is anticipated during the first half of 2022.
GSK Partnered Programs

JEMPERLI (dostarlimab), our proprietary anti-PD-1 antagonist antibody under an immune-oncology partnership with GSK, was approved in a second clinical indication by the FDA in August 2021 for the treatment of pan-deficient mismatch repair tumors. We received $20 million from GSK upon this approval.
We announced the signing of a royalty monetization agreement with Sagard Healthcare Royalty Partners where AnaptysBio will receive a $250 million payment upon closing in exchange for JEMPERLI royalties due to AnaptysBio on annual commercial sales below $1 billion and certain future milestones starting October 2021. The aggregate JEMPERLI royalties and milestones to be received by Sagard under this Agreement is capped at certain fixed multiples of the upfront payment. The closing of the transaction is subject to the satisfaction of customary closing conditions and is anticipated by year-end 2021.
Third Quarter Financial Results

Cash, cash equivalents and investments totaled $389.3 million as of September 30, 2021, compared to $411.2 million as of December 31, 2020, for a decrease of $21.9 million. The decrease relates primarily to cash used for operating activities.
Collaboration revenue was $20.9 million and $62.2 million for the three and nine months ended September 30, 2021. The $20.9 million earned during the third quarter primarily relates to milestone and royalty revenue for the US approval of JEMPERLI (dostarlimab), compared to zero and $15.0 million of milestone revenue for the three and nine months ended September 30, 2020.
Research and development expenses were $22.2 million and $71.7 million for the three and nine months ended September 30, 2021, compared to $19.5 million and $58.5 million for the three and nine months ended September 30, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
General and administrative expenses were $5.4 million and $16.1 million for the three and nine months ended September 30, 2021, compared to $4.8 million and $13.8 million for the three and nine months ended September 30, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
Net loss was $6.7 million and $25.3 million for the three and nine months ended September 30, 2021, or a net loss per share of $0.24, and $0.92, compared to a net loss of $23.8 million and $53.6 million for the three and nine months ended September 30, 2020, or a net loss per share of $0.87 and $1.96.
Financial Guidance

Following the anticipated closing of the Sagard royalty monetization transaction by the end of 2021, we anticipate ending 2021 with approximately $600 million in cash and will continue to operate in a capital-efficient manner.

On November 4, 2021, Puma Biotechnology, Inc. (the "Company") reported that it entered into an Open Market Sale AgreementSM (the "Sale Agreement") with Jefferies LLC (the "Agent"), pursuant to which the Company may offer and sell shares of the Company’s common stock having an aggregate offering price of up to $50,000,000, from time to time, in any method that is deemed to be an "at the market" offering as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, (the "Securities Act") through the Agent (Filing, 8-K, Puma Biotechnology, NOV 4, 2021, View Source [SID1234594447]). Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from the Company equal to 3.0% of the gross proceeds of any shares of common stock sold under the Sale Agreement.

The Company is not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sale Agreement. Unless the Sales Agreement is otherwise terminated pursuant to its terms, the Company may sell shares pursuant to the Sales Agreement for so long as the registration statement is effective, which effectiveness will expire in July 2024. No assurance can be given that the Company will sell any shares of common stock under the Sale Agreement, or, if it does, as to the price or amount of shares of common stock that it sells or the dates when such sales will take place.

In the Sale Agreement, the Company agreed to indemnify the Agent against certain liabilities, including under the Securities Act, or to contribute payments that the Agent may be required to make because of such liabilities.

The shares of common stock sold pursuant to the Sale Agreement will be offered pursuant to a shelf registration statement on Form S-3 (File No. 333‑257687), which was declared effective by the U.S. Securities and Exchange Commission ("SEC") on July 13, 2021. The Company filed a prospectus supplement with the SEC on November 4, 2021 in connection with the offer and sale of shares of the Company’s common stock pursuant to the Sale Agreement.

A copy of the Sale Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the Sale Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sale Agreement.

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On November 4, 2021 Genmab A/S (Nasdaq: GMAB) reported that it is improving its 2021 financial guidance published on August 11, 2021 (Press release, Genmab, NOV 4, 2021, View Source [SID1234594446]). The improved guidance is driven primarily by increased royalty revenue related to the net sales of DARZALEX (daratumumab), both intravenous and subcutaneous formulations, and lower operating expense resulting from timing of investments for R&D activities and organizational capability build.

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Genmab’s projected revenue for 2021 primarily consists of DARZALEX royalties. Such royalties are based on Genmab’s revised estimate of DARZALEX 2021 net sales of USD 5.9–6.2 billion compared to Genmab’s previous estimate of USD 5.6-5.9 billion.

Genmab’s financial results for the first nine months of 2021 will be published on November 10, 2021.

The above expectations are based on assumptions including those described on pages 5 and 6 of the Interim Report for the First Half of 2021 (Company Announcement No. 60 / 2021).

On November 4, 2021, Fate Therapeutics, Inc. (the "Company") reported that filed a registration statement on Form S-3ASR (the "Registration Statement") under Rule 415 of the Securities Act of 1933, as amended (the "Securities Act") (Press release, Fate Therapeutics, NOV 4, 2021, View Source [SID1234594445]). Pursuant to such Registration Statement, the Company may issue and sell from time to time securities consisting of (i) the Company’s common stock, par value $0.001 per share (the "Common Stock"), (ii) the Company’s preferred stock, par value $0.001 per share (the "Preferred Stock" together with the Common Stock, the "Equity Securities"), (iii) debt securities ("Debt Securities"), which may be either senior debt securities, subordinated debt securities, senior convertible debt securities or subordinated convertible debt securities, (iv) warrants or other rights to purchase Common Stock ("Warrants"), and (v) units comprised of shares of Common Stock, shares of Preferred Stock, Debt Securities and Warrants in any combination.

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In addition, on November 4, 2021, the Company entered into an Open Market Sale AgreementSM (the "Agreement") with Jefferies LLC ("Jefferies") with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its Common Stock having an aggregate offering price of up to $350,000,000 (the "Placement Shares"), through Jefferies as its sales agent. The issuance and sale, if any, of the Placement Shares may be by any method permitted by law deemed to be an "at-the-market offering" as defined in Rule 415 of the Securities Act, including, without limitation, sales made directly on the Nasdaq Global Market ("Nasdaq"), or on any other existing trading market for the Common Stock.

The Company is not obligated to make any sales of Common Stock, and Jefferies is not required to sell any specific number or dollar amount of shares of the Common Stock, under the Agreement. The Company or Jefferies may suspend or terminate the offering of Placement Shares upon notice to the other party and subject to other conditions.

Subject to the Company’s request to sell Placement Shares, Jefferies will act as the Company’s sales agent on a best efforts basis and use commercially reasonable efforts to sell on the Company’s behalf, from time to time consistent with its normal sales practices and applicable state and federal laws, rules and regulations and Nasdaq rules, such Placement Shares based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Jefferies a commission equal to 3.0 percent (3.0%) of the gross proceeds of any Placement Shares sold through Jefferies under the Agreement, and also has provided Jefferies with customary indemnification and contribution rights.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith and incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.