On April 30, 2020 Amgen (NASDAQ:AMGN) reported financial results for the first quarter of 2020 and discussed the company’s response to the COVID-19 pandemic (Press release, Amgen, APR 30, 2020, View Source [SID1234556837]).
First Quarter Performance
Key results include:

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Total revenues increased 11% to $6.2 billion in comparison to the first quarter of 2019, driven by higher unit demand, offset partially by lower net selling prices.

Product sales increased 12% globally, driven by volume growth across a number of our newer products, including Otezla (apremilast), Repatha (evolocumab), MVASI (bevacizumab-awwb), KANJINTI (trastuzumab-anns) and Evenity (romosozumab-aqqg), offset partially by declines in select products from the impact of biosimilar and generic competition.

GAAP earnings per share (EPS) decreased 3% to $3.07 driven by the amortization of costs associated with our Nov. 21, 2019 acquisition of Otezla, offset partially by increased revenues.

GAAP operating income decreased 5% to $2.4 billion and GAAP operating margin decreased 6.8 percentage points to 40.0% driven by the amortization of intangible assets from our Otezla acquisition.

Non-GAAP EPS increased 17% to $4.17 driven by increased revenues and fewer weighted-average shares outstanding.

Non-GAAP operating income increased 15% to $3.2 billion and non-GAAP operating margin increased 1.5 percentage points to 53.9%.

The Company generated $2.0 billion of free cash flow in the first quarter versus $1.7 billion in the first quarter of 2019.

2020 total revenues guidance reaffirmed at $25.0-$25.6 billion; EPS guidance revised to $10.65-$11.45 on a GAAP basis and reaffirmed at $14.85-$15.60 on a non-GAAP basis.

"I am inspired by the many ways my colleagues at Amgen and others across the industry are stepping up to meet the greatest public health challenge of our lifetime," said Robert A. Bradway, chairman and chief executive officer. "We are committed to an uninterrupted supply of our medicines to patients; advancing potential new medicines to treat serious diseases, including COVID-19; making a difference in the communities where we live and work; and creating long-term value for shareholders."

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS

References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and to "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations.
Product Sales Performance

Total product sales increased 12% for the first quarter of 2020 versus the first quarter of 2019 driven by 15% volume growth.

Prolia (denosumab) sales increased 10% driven by higher unit demand.

EVENITY launched in the U.S. and Japan in the first half of 2019, generating $100 million of sales in the first quarter of 2020.

Repatha sales increased 62% driven by 98% volume growth, offset partially by lower net selling price. Repatha’s net selling price was impacted by the removal of our original list price option to improve patient affordability, especially for Medicare patients.

Aimovig (erenumab-aooe) sales increased 20% driven by 46% volume growth, offset partially by lower net selling price as we expanded patient access.

Parsabiv (etelcalcetide) sales increased 39% driven by higher unit demand, offset partially by lower net selling price.

Otezla was acquired on Nov. 21, 2019 and generated $479 million of sales in the first quarter of 2020.

Enbrel (etanercept) sales were flat as favorable changes to estimated sales deductions and inventory were offset by lower unit demand and lower net selling price.

AMGEVITA (adalimumab) generated $86 million of sales in the first quarter of 2020 and is the most prescribed adalimumab biosimilar in Europe.

KYPROLIS (carfilzomib) sales increased 14% driven by higher unit demand and to a lesser extent, higher net selling price.

XGEVA (denosumab) sales increased 2% driven by higher unit demand.

Vectibix (panitumumab) sales increased 19% driven by higher unit demand.

Nplate (romiplostim) sales increased 15% driven by higher unit demand.

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS

BLINCYTO (blinatumomab) sales increased 36% driven by higher unit demand.

KANJINTI generated $119 million of sales in the first quarter of 2020.

MVASI generated $115 million of sales in the first quarter of 2020.

Neulasta (pegfilgrastim) sales decreased 40% driven by the impact of competition on unit demand and net selling price.

NEUPOGEN (filgrastim) sales decreased 11% driven by the impact of competition on unit demand.

EPOGEN (epoetin alfa) sales decreased 29% driven by lower net selling price and unfavorable changes to estimated sales deductions.

Aranesp (darbepoetin alfa) sales increased 2% driven by higher unit demand and favorable changes in inventory, offset by lower net selling price.

Sensipar/Mimpara (cinacalcet) sales decreased 42% driven by the impact of competition on unit demand, offset partially by favorable changes to estimated sales deductions and inventory.

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS

** Other includes GENSENTA, IMLYGIC, Corlanor and Bergamo.
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:

Total Operating Expenses increased 23% driven by Otezla-related expenses, including the amortization of intangible assets. Cost of Sales margin increased 5.7 percentage points driven by amortization of intangible assets acquired in the Otezla acquisition and an increase in milestone payments, offset partially by lower manufacturing costs. Research & Development (R&D) expenses increased 8% driven by higher late-stage development program support of our oncology portfolio, primarily AMG 510 (sotorasib), along with the recently acquired Otezla, offset partially by recoveries from our collaboration with BeiGene. Selling, General & Administrative (SG&A) expenses increased 14% due to our first full quarter of Otezla commercial-related expenses.

Operating Margin decreased 6.8 percentage points to 40.0% driven by the amortization of intangible assets from our Otezla acquisition.

Tax Rate decreased 4.2 percentage points due primarily to amortization related to the Otezla acquisition, changes in jurisdictional mix of earnings and an increase in net discrete tax benefits.

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS
Page 5

On a non-GAAP basis:

Total Operating Expenses increased 7% driven by Otezla-related expenses. Cost of Sales margin decreased 1.6 percentage points driven by lower manufacturing costs, offset partially by an increase in milestone payments. R&D expenses increased 8% driven by higher late-stage development program support of our oncology portfolio, primarily AMG 510 (sotorasib), along with the recently acquired Otezla, offset partially by recoveries from our collaboration with BeiGene. SG&A expenses increased 12% due to our first full quarter of Otezla commercial-related expenses.

Operating Margin increased 1.5 percentage points to 53.9%.

Tax Rate decreased 1.8 percentage points due primarily to changes in jurisdictional mix of earnings and an increase in net discrete tax benefits.
$Millions, except percentages

Cash Flow and Balance Sheet

The Company generated $2.0 billion of free cash flow in the first quarter of 2020 versus $1.7 billion in the first quarter of 2019.

The Company’s first quarter 2020 dividend of $1.60 per share was declared on Dec. 11, 2019, and was paid on March 6, 2020, to all stockholders of record as of Feb. 14, 2020, representing a 10% increase from the first quarter of 2019.

During the first quarter, the Company repurchased 4.3 million shares of common stock at a total cost of $933 million. At the end of the first quarter, the Company had $5.5 billion remaining under its stock repurchase authorization.

2020 Guidance
For the full year 2020, the Company reaffirmed total revenues and non-GAAP EPS guidance:

Total revenues in the range of $25.0 billion to $25.6 billion, unchanged from previous guidance.

On a GAAP basis, EPS in the range of $10.65 to $11.45 and a tax rate in the range of 10.5% to 11.5%.

On a non-GAAP basis, EPS in the range of $14.85 to $15.60 and a tax rate in the range of 13.5% to 14.5%, unchanged from previous guidance.

Capital expenditures to be approximately $600 million.

First Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
AMG 510 (sotorasib)

The Company will present the following clinical data as part of the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, May 29-31:

Updated results from the Phase 1 dose escalation study in patients with advanced colorectal cancer.

Updated results from the Phase 1 dose escalation study in patients with advanced solid tumors other than non-small-cell lung cancer (NSCLC) and colorectal cancer.

The Company reiterated its expectation of initial data in 2020 from a potentially pivotal Phase 2 monotherapy study in patients with advanced NSCLC, including at least six months of response data.

BiTE Programs

The Company expects initial data from Phase 1 dose escalation studies of the following half-life extended BiTE molecules in H2 2020:

AMG 160 targeting PSMA (prostate specific membrane antigen)

AMG 701 targeting BCMA (B-cell maturation antigen)

AMG 757 targeting DLL3 (Delta-like ligand 3)

Updated results from the Phase 1 dose escalation study of AMG 330, a bispecific T-cell engager molecule targeting CD33, in patients with relapsed/refractory acute myeloid leukemia will be presented as part of the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, May 29-31.

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS
Page 7

KYPROLIS

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020 for the supplemental New Drug Application (sNDA) to expand the Prescribing Information to include KYPROLIS in combination with dexamethasone and DARZALEX (daratumumab) for patients with relapsed or refractory multiple myeloma based on data from the Phase 3 CANDOR study.

In February, a variation to the marketing authorization application was submitted to the European Medicines Agency to expand the indication for Kyprolis in relapsed multiple myeloma based on data from the Phase 3 CANDOR study.
XGEVA

In April, a marketing authorization for the treatment of skeletal related events was accepted for review by the Center for Drug Evaluation in China. XGEVA is included in our strategic collaboration with BeiGene.
ABP 798 (biosimilar rituximab)

The FDA has set a Biosimilar User Fee Act target action date of Dec. 19, 2020 for the Biologics License Application for ABP 798, a biosimilar candidate to Rituxan (rituximab).
Otezla

Data from the Phase 3 study in patients with mild-to-moderate psoriasis are expected in Q2 2020.

In April, the U.S. Food and Drug Administration (FDA) approved the sNDA to add scalp psoriasis data to the U.S. Prescribing Information.

In April, the European Commission (EC) approved an additional indication for the treatment of adult patients with oral ulcers associated with Behçet’s Disease who are candidates for systemic therapy.

Tezepelumab

The Company reiterated its expectation of data from the Phase 3 NAVIGATOR study in patients with severe uncontrolled asthma by the end of 2020.
Omecamtiv mecarbil

In February, the Data Monitoring Committee for the Phase 3 GALACTIC-HF study completed the second and final planned interim analysis for futility and superiority and recommended that the study continue without changes to its conduct.

The Company reiterated its expectation of data from GALACTIC-HF in Q4 2020.
Repatha

In March, the Company announced that Repatha significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients who are human immunodeficiency virus-positive and have high LDL-C despite stable background lipid-lowering therapy.
AMG 890

A Phase 2 study is expected to begin in the second half of 2020 for AMG 890, a small interfering RNA molecule that lowers lipoprotein(a).

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS
Page 8

COVID-19

The Company announced that Otezla, an oral treatment approved in more than 50 countries for inflammatory diseases such as psoriasis and psoriatic arthritis, will be investigated as a potential immunomodulatory treatment in adult patients with COVID-19 in upcoming platform trials.

In April, the Company announced a collaboration with Adaptive Biotechnologies to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19.

The Company provided the following updates on aspects of its R&D activities

Study start-up activities are continuing where possible to allow rapid site activation and enrollment when that becomes feasible.

Study procedures are being implemented consistent with recent guidance from regulators to maintain patient safety and study data integrity.

Enrollment is paused in clinical trials where there is uncertainty around the ability of sites to ensure subject safety or data integrity.

Research activities are increasing in various geographies as the situation safely permits.

Medical conferences and journals are being engaged to ensure continued dissemination of important data in a timely manner.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.
DARZALEX is a registered trademark of Janssen Biotech, Inc.
Rituxan is a registered trademark of Biogen Inc.
Tezepelumab is being developed in collaboration with AstraZeneca
Omecamtiv mecarbil is being developed under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier

On April 30, 2020 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the three months ended March 31, 2020 (Press release, PRA Health Sciences, APR 30, 2020, View Source [SID1234556836]).

"During these unprecedented times, we have focused on the health and safety of employees putting into practice what we have always said about our people being our most important asset. Due to the ongoing impact of COVID-19, we have prioritized employees’ well-being and have worked diligently with our customers to ensure that we mitigate the impact that this pandemic is having on their studies," said Colin Shannon, PRA’s President and Chief Executive Officer.

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"Our first quarter financial results were impacted by the pandemic, particularly during the latter part of the quarter, when decisions on new business were delayed and stay-at-home orders created challenges in conducting our business. However, we still produced revenue and earnings that were in line with the guidance we provided back in February. As the world started moving into lockdown we worked creatively with clients to help them find solutions for their on-going studies. Through the use of our mobile health platform and our remote monitoring technology, we were able to mitigate some of the impact the lockdown had on our financial results.

"With all the uncertainty of how this pandemic will unfold, it is extremely difficult to estimate the impact to our financial results, but we will continue to manage our business in a very fiscally responsible manner and continue to be innovative in finding solutions for our clients. We have significantly reduced our debt levels over the past few years, and we are well-positioned to weather the challenging economic conditions that we may continue to face. I would also like to add that we are extremely thankful to all those who are helping the world get through this global pandemic."

Net new business for our Clinical Research segment for the three months ended March 31, 2020 excluding reimbursement revenue was $604.7 million, representing a net book-to-bill ratio of 1.10 for the period. Net new business for our Clinical Research segment for the three months ended March 31, 2020 including reimbursement revenue was $955.9 million, representing a net book-to-bill of 1.32 for the period. During the quarter, our net new business awards were impacted by the COVID-19 pandemic as business development activities began to slow at the end of the quarter with bid-defense meetings and study award decisions being postponed due to restrictions put in place as a result of the pandemic. This net new business, excluding reimbursement revenue, contributed to an ending backlog of $4.7 billion at March 31, 2020.

For the three months ended March 31, 2020, revenue was $783.7 million, which represents growth of 8.5%, or $61.7 million, compared to the three months ended March 31, 2019 at actual foreign exchange rates. On a constant currency basis, revenue grew $67.0 million, an increase of 9.3% compared to the first quarter of 2019. By segment, the Clinical Research segment generated revenues of $726.1 million, while the Data Solutions segment generated revenues of $57.6 million.

Direct costs, exclusive of depreciation and amortization, were $403.9 million during the three months ended March 31, 2020 compared to $377.9 million for the three months ended March 31, 2019 at actual foreign exchange rates. On a constant currency basis, direct costs increased $32.5 million compared to the first quarter of 2019. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment and increased data costs in our Data Solutions segment. Direct costs were 51.5% of revenue during the first quarter of 2020 compared to 52.3% of revenue during the first quarter of 2019.

Selling, general and administrative expenses were $107.0 million during the three months ended March 31, 2020 compared to $97.1 million for the three months ended March 31, 2019. Selling, general and administrative costs were 13.6% of revenue during the first quarter of 2020 compared to 13.4% of revenue during the first quarter of 2019.

GAAP net income was $40.7 million for the three months ended March 31, 2020, or $0.63 per share on a diluted basis, compared to GAAP net income of $44.1 million for the three months ended March 31, 2019, or $0.66 per share on a diluted basis.

EBITDA was $103.3 million for the three months ended March 31, 2020, representing a decrease of 7.9% compared to the three months ended March 31, 2019. Adjusted EBITDA was $112.1 million for the three months ended March 31, 2020, representing a decrease of 4.3% compared to the three months ended March 31, 2019.

Adjusted net income was $67.3 million for the three months ended March 31, 2020, representing a decrease of 8.1% compared to the three months ended March 31, 2019. Adjusted net income per diluted share was $1.05 for the three months ended March 31, 2020, representing a decrease of 4.5% compared to the three months ended March 31, 2019.

Guidance

The Company is withdrawing its full year 2020 guidance. Due to the uncertain scope and duration of the COVID-19 pandemic and uncertain timing of global recovery and economic normalization, the Company is unable to estimate with confidence the full-year overall impact on its global operations.

For Q2 2020, the Company expects to achieve total revenues between $705.0 million and $740.0 million, GAAP net income per diluted share of between $0.32 and $0.46, adjusted net income per diluted share of between $0.75 and $0.90, and an effective income tax rate of 23%.

Our Q2 2020 guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30. All other foreign currency exchange rates are as of March 31, 2020.

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our Q2 2020 guidance to the corresponding GAAP measures is included in this press release.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on May 1, 2020, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 7450977. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 7450977.

Additional Information

A financial supplement with first quarter 2020 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q1 2020 Earnings Presentation."

On April 30, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Wednesday, May 6, 2020 at 5pm ET to discuss first quarter 2020 financial results and provide a corporate update (Press release, Ultragenyx Pharmaceutical, APR 30, 2020, http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-first-quarter-2020-financial [SID1234556835]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (International) and enter the passcode 9455159. The replay of the call will be available for one year.

On April 30, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE), a preclinical-stage biotechnology company focused on developing next generation therapies to treat rare genetic diseases caused by mutant genes, reported the closing of its previously announced underwritten public offering of 6,037,500 shares of its common stock (inclusive of 787,500 shares that were sold pursuant to the underwriters’ full exercise of their option to purchase additional shares of NeuBase’s common stock), at a price to the public of $6.00 per share (Press release, NeuBase Therapeutics, APR 30, 2020, View Source [SID1234556834]). The net proceeds to NeuBase from the offering are expected to be approximately $33.3 million, after deducting the underwriting discounts and commissions and other estimated offering expenses payable by NeuBase. NeuBase intends to use the net proceeds from this offering for working capital and general corporate purposes and to advance the development of its product candidates and expand its pipeline.

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Oppenheimer & Co. Inc. and BTIG acted as the joint book-running managers for the offering, and Chardan and National Securities Corporation, a wholly-owned subsidiary of National Holdings, Inc. (Nasdaq: NHLD), acted as the co-managers.

The securities described above were offered by NeuBase pursuant to a shelf registration statement on Form S-3 (File No. 333-220487) previously filed with the Securities and Exchange Commission (the "SEC") on September 15, 2017 and declared effective by the SEC on September 27, 2017. A final prospectus supplement and the accompanying prospectus relating to and describing the offering was filed with the SEC. Electronic copies of the preliminary prospectus supplement and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by e-mail at [email protected], or BTIG, LLC, Attention: Equity Capital Markets, 65 East 55th Street, New York, NY 10022, by telephone at (212) 593-7555 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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 jurisdiction.

On April 30, 2020 Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing next-generation human enzyme therapeutics as solutions for rare and other high-burden diseases, reported the closing of its public offering of 15,442,303 shares of its common stock at a public offering price of $4.75 per share, which includes the exercise in full of the underwriters’ option to purchase 3,789,473 shares of common stock (Press release, Aeglea BioTherapeutics, APR 30, 2020, View Source [SID1234556833]). In addition, and in lieu of common stock, Aeglea sold to certain investors pre-funded warrants to purchase up to an aggregate of 13,610,328 shares of common stock at a purchase price of $4.7499 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds to Aeglea, before deducting underwriting discounts and commissions and estimated offering expenses payable by Aeglea, were approximately $138 million.

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J.P. Morgan Securities LLC, Evercore Group L.L.C. and Piper Sandler & Co. acted as joint book-running managers in the offering. JonesTrading Institutional Services LLC and Needham & Company, LLC acted as co-managers.

The securities described above were offered by Aeglea pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering was made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying base prospectus may also be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by e-mail at: [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected].

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