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SCYNEXIS Reports Second Quarter 2019 Financial Results and Provides Company Update

On August 7, 2019 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended June 30, 2019, and provided an update on recent clinical developments (Press release, Scynexis, AUG 7, 2019, View Source [SID1234538449]).

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"We are pleased with the rapid enrollment observed in our Phase 3 VANISH program for vulvovaginal candidiasis (VVC), which underscores the significant unmet need in this patient population," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We look forward to sharing top-line data from the U.S. study in the first quarter of 2020, and from the global study in the second quarter of 2020. We are making great progress toward our goal of a planned New Drug Application (NDA) submission for VVC in the second half of 2020."

Dr. Taglietti continued, "We are committed to maximizing the full value of ibrexafungerp in multiple settings. As we approach important milestones for our VVC registration program, we are also excited by the promising data supporting the potential role of oral ibrexafungerp as a treatment for a broad range of life-threatening, hospital-based, fungal infections, including Candida auris and other multidrug-resistant pathogens for which few existing treatment options are available."

Ibrexafungerp (formerly SCY-078), the first representative of a novel family of antifungal compounds referred to as triterpenoids, is being developed for oral and intravenous (IV) administration and is in clinical development for the treatment of both serious outpatient fungal infections, including VVC, and hospital-based life-threatening fungal infections, including invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, ibrexafungerp could potentially address significant unmet medical needs as the only oral non-azole antifungal therapy.

Ibrexafungerp Update

Significant progress made in Phase 3 VANISH program evaluating the safety and efficacy of oral ibrexafungerp (300mg BID for one day) versus placebo for the treatment of VVC
The VANISH Phase 3 program is comprised of two Phase 3, randomized, double-blind, placebo-controlled, multicenter studies:
The VANISH 303 study is being conducted in U.S. centers and is expected to enroll approximately 350 patients; enrollment in the study is exceeding expectations and SCYNEXIS anticipates top-line data in the first quarter of 2020. More information about this study can be found at: View Source
The global VANISH 306 study is being conducted in U.S. and European centers and is expected to enroll approximately 350 patients; enrollment is progressing as planned, and the Company anticipates top-line data in the second quarter of 2020. More information about this study can be found at: View Source
All NDA preparatory activities remain on track to support a planned NDA submission in the second half of 2020.
Phase 3 CANDLE study evaluating the safety and efficacy of oral ibrexafungerp versus placebo for the prevention of recurrent VVC is on track to start enrollment this quarter following the Special Protocol Assessment (SPA) agreement received from the U.S. Food and Drug Administration (FDA) in July 2019
The Company recently announced an agreement with the FDA under a SPA, on the design, trial population, endpoints and statistical analysis of the CANDLE study, a pivotal Phase 3 clinical trial of oral ibrexafungerp for the prevention of recurrent VVC. This SPA provides agreement with the FDA that the Phase 3 protocol design adequately addresses efficacy objectives that, if met, would form the primary basis of a regulatory submission for approval of oral ibrexafungerp for the prevention of recurrent VVC, an indication with no FDA-approved therapies.
The CANDLE study is a global Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of oral ibrexafungerp (300mg BID for one day, given once per month for a total of six treatment days) compared to placebo in female patients with recurrent VVC (defined as three or more episodes of VVC in the past 12 months, including the episode at screening). The study is being conducted at approximately 50 sites and is expected to enroll approximately 320 patients. Enrollment is expected to commence this quarter with an expected supplemental NDA submission in 2021.
More information about the CANDLE study can be found at: View Source
An open-label sub-study within CANDLE will evaluate the efficacy of oral ibrexafungerp in fluconazole-failure VVC patients
All patients in the CANDLE study will initially receive three doses of oral fluconazole to treat their acute episode of VVC present at screening before progressing to the prevention phase of the study.
Patients who fail to sufficiently respond to fluconazole treatment for their acute episode will be included in the sub-study, in which they will be offered one day of oral ibrexafungerp treatment (300mg BID) for their unresolved acute episode.
More information about the sub-study within the CANDLE study can be found at: View Source
Continued advancement of oral ibrexafungerp for hospital-based invasive fungal infections with two Phase 3 studies (FURI in refractory infections and CARES in Candida auris infections) and one Phase 2 study in invasive aspergillosis (SCYNERGIA)
Enrollment is ongoing in the Company’s refractory invasive fungal infection (rIFI) program, which comprises two open-label Phase 3 studies (FURI and CARES) designed to support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). Positive clinical findings from these studies have so far reinforced the potential role of oral ibrexafungerp as a novel therapy to combat severe and difficult-to-treat fungal infections, including multidrug-resistant Candida auris. More information about these studies can be found at:
View Source
View Source
Enrollment continues in the Phase 2 SCYNERGIA study, a randomized, double-blind clinical trial assessing the safety and efficacy of oral ibrexafungerp in combination with voriconazole, compared to voriconazole alone. More information about this study can be found at: View Source
Data presented at the American Society for Microbiology (ASM) Microbe 2019 Meeting demonstrates broad potential utility of ibrexafungerp for the treatment and prevention of multiple severe fungal infections
A total of nine presentations revealed data further demonstrating the potential of ibrexafungerp as a treatment for invasive fungal infections (visit scynexis.com/science to view the presentations). The data presented highlighted the potent activity of ibrexafungerp against difficult-to-treat and/or multidrug-resistant pathogens, including Candida auris, Candida glabrata, and Pneumocystis pneumonia. The activity of ibrexafungerp was tested against many Candida strains resistant to echinocandins, the current standard of care for these infections, and potent activity of ibrexafungerp was observed.
In vivo chronic toxicology studies further support the safety profile of ibrexafungerp, allowing for patients suffering from invasive fungal infections to use oral ibrexafungerp for an extended period of time and enabling its potential development as a prophylactic agent and as a treatment for chronic fungal infections.
Corporate Highlight

Management Team strengthened with appointment of Dr. Nkechi Azie as Vice President of Clinical Development.
SCYNEXIS announced the appointment of Nkechi Azie, MD, MBA, FIDSA, as Vice President of Clinical Development. Dr. Azie will lead clinical development activities and strengthen medical affairs efforts in anticipation of ibrexafungerp’s potential approval and commercial launch. She joins SCYNEXIS with over 25 years of experience in drug development and medical affairs, having worked in therapeutic areas including infectious disease, women’s health and immunology.
Second Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $35.2 million as of June 30, 2019, with net working capital of $28.9 million. Based upon its existing operating plan, SCYNEXIS believes its existing cash, cash equivalents, short-term investments, and the sale of a portion of its New Jersey net operating losses (NOLs), will be sufficient to fund operations beyond the planned NDA submission for acute VVC in the second half of 2020.

Research and development expenses increased to $8.5 million for the quarter ended June 30, 2019, compared to $5.6 million in the second quarter of 2018. The increase of $2.9 million, or 51%, was primarily driven by an increase of $3.2 million in clinical development costs, an increase of $0.4 million in chemistry, manufacturing, and controls (CMC) costs, a net increase in other research and development costs of $0.6 million, offset in part by a decrease of $1.3 million in preclinical development expense.

Selling, general and administrative expenses in the second quarter of 2019 increased to $2.8 million, compared with $2.1 million in the second quarter of 2018. The increase of $0.7 million, or 31%, was primarily driven by a $0.4 million increase in business development costs.

Total other income increased to $2.8 million in the second quarter of 2019, compared to a $3.1 million loss in the second quarter of 2018. The increase in other income is attributable to the non-cash gains recognized during the second quarter of 2019 of $2.0 million and $1.3 million associated with the fair value adjustments for warrant liabilities and derivative liability, respectively.

Net loss for the second quarter of 2019 was $8.4 million, or $0.16 per share. This compares with a net loss for the second quarter of 2018 of $10.8 million, or $0.23 per share.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and VVC (including prevention of recurrent VVC), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

CytomX Therapeutics Announces Second Quarter 2019 Financial Results and Provides Business Update

On August 7, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported second quarter 2019 financial results (Press release, CytomX Therapeutics, AUG 7, 2019, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-second-quarter-2019-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-second-quarter-2019-financial" rel="nofollow">View Source [SID1234538448]).

As of June 30, 2019, CytomX had cash, cash equivalents and short-term investments of $349.1 million.

"CytomX continues to make progress across its pipeline. Highlights of the second quarter included additional presentations of clinical data for our lead, wholly owned assets, CX-072 and CX-2009, which further demonstrated the potential of these two novel anti-cancer agents," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "Our clinical work to date with our lead programs provides validation for our unique approach to targeting antibody therapies to the tumor microenvironment and, accordingly, the discovery and development of new and differentiated treatments for cancer patients."

Business Highlights and Recent Developments

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

CX-072 is a wholly owned Probody therapeutic targeting PD-L1, a clinically and commercially validated anti-cancer target.
CytomX presented updated clinical data from monotherapy expansion cohorts (Part D) of the PROCLAIM-CX-072 Phase 1/2 study, evaluating the safety and efficacy of CX-072 in multiple tumor types at 10 mg/kg at the 2019 Annual Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These data demonstrated a favorable safety profile and evidence of anti-cancer activity in certain patients with triple negative breast cancer, anal squamous cell carcinoma, cutaneous squamous cell carcinoma and undifferentiated pleomorphic sarcoma.
David Page, M.D., Medical Oncologist, Providence Cancer Center presented clinical data from PROCLAIM-CX-072 monotherapy and in combination with ipilimumab (YERVOY) as part of a Poster Discussion Session at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a wholly owned, first in class Probody drug conjugate (PDC) targeting CD166, a novel antigen that is broadly and highly expressed in many types of cancer.
CytomX reported preliminary data from the dose-escalation phase (Part A and A2) of the ongoing PROCLAIM-CX-2009 Phase 1/2 study, evaluating the safety and antitumor activity of CX-2009 in seven selected tumor types, at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CX-2009 was generally well tolerated. Single agent anti-cancer activity was observed in certain patients with breast cancer, ovarian cancer and head and neck cancer.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program

CX-2029 is a first in class PDC targeting CD71, the Transferrin Receptor, a highly efficient cellular mechanism for the internalization of antibody drug conjugates in preclinical models.
CD71 is widely expressed on normal tissues and therefore is considered to be an undruggable clinical target for conventional antibody drug conjugate technology.
CytomX discovered and is developing CX-2029 in collaboration with AbbVie to potentially turn CD71 into a druggable target.
CytomX continues to enroll patients in the PROCLAIM-CX-2029 Phase 1/2 study evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas.
BMS-986249 (CTLA-4 Probody Therapeutic) Clinical Program

Bristol-Myers Squibb (BMS) continues enrollment in a Phase 1/2 dose escalation clinical study evaluating BMS-986249 alone and in combination with OPDIVO (nivolumab) in solid tumors that are advanced and have spread.
BMS is preparing to initiate the Phase 2 portion of this clinical trial, upon which CytomX is entitled to a $10 million milestone payment.
AbbVie Second Target Selection Under Strategic Oncology Collaboration

In July 2019, CytomX announced its partner AbbVie selected a second target under the companies’ 2016 Discovery Collaboration and Licensing Agreement to discover and develop Probody drug conjugates. The target selection triggered a $10 million payment to CytomX.
Second Quarter 2019 Financial Results
Cash, cash equivalents and short-term investments totaled $349.1 million as of June 30, 2019, compared to $436.1 million as of December 31, 2018. The decrease of $87.0 million for the six months ended June 30, 2019 included certain infrequent payments such as $5.0 million for the acquisition from an Astellas subsidiary of technical know-how related to drug conjugate linker-toxin and CD3-based bispecific antibody technology in the first quarter, a $13.7 million federal tax payment for the 2018 tax return filing in the second quarter and approximately $4.7 million related to the UCSB license agreement, also in the second quarter.

Revenue was $9.0 million for the three months ended June 30, 2019, compared to $21.3 million for the three months ended June 30, 2018. The decrease in revenue of $12.3 million for the three months ended June 30, 2019 compared to the corresponding period in 2018 was primarily due to the $21.0 million milestone payment (net of the associated sublicense fee of $4.0 million) earned in May 2018 under the CD71 Agreement with AbbVie, of which $9.9 million was recognized in the second quarter of 2018 reflecting the percentage completed-to-date of the project related to this milestone.

Research and development expenses increased $5.3 million during the three months ended June 30, 2019 compared to the corresponding period in 2018. The increase was attributable to $3.4 million in license fees and maintenance fees related to an amendment to the UCSB Licensing Agreement (which included the issuance of 150,000 shares of Company common stock valued at $1.6 million, an upfront payment of $1.0 million and an additional annual maintenance fee of $0.8 million), an increase of $0.8 million sublicense expense pertaining to the $10.0 million milestone payment earned upon the AbbVie selection of the second target in the second quarter of 2019 under the Amended and Restated Discovery Collaboration and License Agreement, an increase of $2.4 million in personnel-related expenses due to an increase in headcount, an increase of $0.5 million in clinical related expenses resulting from increased clinical trial activities and an increase of $0.7 million in the allocation of information technology and facilities related expenses resulting from an increase in headcount, partially offset by a decrease of $2.3 million in laboratory contracts and services as a result of timing of manufacturing activities.

General and administrative expenses increased by $0.4 million during the three months ended June 30, 2019 compared to the corresponding period in 2018. The increase was attributable to an increase of $1.0 million in personnel-related expenses due to an increase in headcount, an increase of $0.3 million for dues and subscriptions primarily related to software and other IT services and an increase of $0.2 million in professional service expenses, partially offset by a decrease of $0.5 million in consulting and contract services and a decrease of $0.7 million through increased expense allocation of information technology and facilities-related expenses to research and development due to an increase in research and development headcount.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 7785617. An archive of the webcast will be available on the CytomX website from August 7, 2019, until August 21, 2019.

TRACON Pharmaceuticals Reports Second Quarter 2019 Financial Results And Provides Corporate Update

On August 7, 2019 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age-related macular degeneration through our license to Santen Pharmaceutical Co. Ltd., and utilizing our product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the second quarter ended June 30, 2019 (Press release, Tracon Pharmaceuticals, AUG 7, 2019, View Source [SID1234538447]).

Recent Corporate Highlights

In August, our partner Santen announced the completion of enrollment in the randomized Phase 2 AVANTE study of DE-122 in combination with Lucentis (ranibizumab) in patients with wet age-related macular degeneration (AMD).

In July, we initiated dosing of the first patient in a Phase 1 study of TJ004309 (CD73 antibody) as a single agent and in combination with Tecentriq (atezolizumab), a PD-L1 checkpoint inhibitor marketed by Roche, in patients with advanced solid tumors.

In June, data from the ongoing Phase 1/2 clinical trial of TRC253 in metastatic castrate resistant prostate cancer patients were published in the 2019 ASCO (Free ASCO Whitepaper) Proceedings. 22 patients who had progressed on prior Xtandi (enzalutamide) or Erleada (apalutamide) treatment were enrolled into one of six cohorts of escalating doses of TRC253. The single patient with a F877L androgen receptor (AR) point mutation at baseline remained on treatment for 49 weeks with a partial response by RECIST. The remaining 21 patients did not have a F877L AR point mutation at baseline, and 48% (10) remained on study for at least 6 months and one patient had a greater than 50% decrease in prostate specific antigen. TRC253 was well-tolerated and no drug-related serious adverse events were reported.
"We are excited to have initiated clinical development of TJ004309 and next look forward to collaborating on up to five bispecific antibodies with I-Mab Biopharma beginning with the first IND in 2020," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We also continue to evaluate opportunities to establish new corporate partnerships. We are focused on ex-U.S. companies with first-in-class, best-in-class or fast follower clinical stage assets that could benefit from accessing our product development platform, which we believe offers a rapid and capital-efficient U.S. drug development and commercialization solution."

Expected Upcoming Milestones

Top-line data, including the primary endpoint of mean change in best corrected visual acuity at six months, from the randomized Phase 2 AVANTE trial of DE-122 in patients with wet AMD are expected in the first half of 2020.

Presentation of Phase 2 data from Phase 1/2 clinical trial of TRC253 in metastatic castrate resistant prostate cancer to Janssen is expected in the second half of 2020, whereupon Janssen will have an exclusive option to reacquire full rights to TRC253 for an opt-in payment of $45 million to TRACON, and obligations to pay regulatory and commercialization milestones totaling up to $137.5 million upon achievement of specified events and a low single-digit royalty on net sales.
Second Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments were $26.3 million at June 30, 2019, compared to $39.1 million at December 31, 2018. We expect our current cash, cash equivalents and short-term investments to fund operations into the third quarter of 2020.

Research and development expenses for the second quarter of 2019 were $4.3 million compared to $8.1 million for the second quarter of 2018. The decrease was primarily attributable to lower manufacturing expenses due to the discontinuation of the TRC105 program.

General and administrative expenses for the second quarter of 2019 were $1.9 million compared to $1.6 million for the second quarter of 2018.

Net loss for the second quarter of 2019 was $6.3 million compared to $9.8 million for the second quarter of 2018.
Investor Conference Call

The Company will hold a conference call today at 4:30 p.m. EDT / 1:30 p.m. PDT to provide an update on corporate activities and to discuss the financial results of its second quarter 2019. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 7498077. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About DE-122 (carotuximab)

DE-122, an ophthalmic formulation of carotuximab, is active in preclinical choroidal neovascularization (CNV) models and designed to enhance the effect of approved VEGF inhibitors used to treat wet AMD. DE-122 is being investigated in the Phase 2 randomized AVANTE trial assessing the efficacy and safety of intravitreal injections in combination with Lucentis (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD.

About TRC253

TRC253 is a novel, orally bioavailable small molecule drug that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F877L mutation. The AR F877L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR. TRC253 is currently being studied in a Phase 1/2 clinical trial in prostate cancer. For more information about the clinical trial, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in a Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

Cambrex to be Acquired by the Permira Funds for $60.00 per Share in Cash

On August 7, 2019 Cambrex Corporation (NYSE: CBM), the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, reported that it has signed a definitive agreement to be acquired by an affiliate of the Permira funds in a transaction valued at approximately $2.4 billion, including Cambrex’s net debt (Press release, Cambrex, AUG 7, 2019, View Source [SID1234538416]). Under the terms of the merger agreement, Cambrex shareholders will receive $60.00 in cash for each share of Cambrex common stock, which represents a 47.1% premium to the August 7 closing stock price and a 37.3% premium to the 60-day volume weighted average closing price leading up to this announcement.

Cambrex has grown to become the premier contract development and manufacturing organization in the small molecule space over the last several years. The recent acquisitions of Halo Pharma in 2018 and Avista Pharma Solutions in 2019 added drug product manufacturing and a full range of early stage and analytical testing services to the company’s leading position in drug substance manufacturing, allowing Cambrex to broaden customer relationships over the full product lifecycle, from pre-clinical through commercial.

"We are excited to announce this transaction with Permira, a global private equity firm that has made significant investments in the pharma services space. This agreement is a strong endorsement of our strategy and represents significant value for our shareholders," commented Steve Klosk, President and CEO of Cambrex. "Cambrex will continue to invest aggressively in our commitment to our global customer base, where we are constantly looking at ways to provide the broadest possible range of world class services."

"We are very excited to back Cambrex in its next phase of growth," said Henry Minello, Principal in the Global Healthcare Group of Permira. "Over many years, Cambrex has built a leading position with best-in-class capabilities and facilities, backed by an excellent reputation for quality and technical expertise. We look forward to partnering with Cambrex’s talented management and employees to support the growth of its integrated services offering."

Completion of the transaction is subject to customary closing conditions, including receipt of approval by Cambrex’s shareholders and customary regulatory approvals. Closing is expected to occur during the fourth quarter of 2019.

The transaction will be financed through a combination of debt and equity financing.

Under the terms of the agreement, Cambrex may actively solicit acquisition proposals from third parties during a 45-day "go-shop" period starting from the date of the agreement (which period may be extended under certain circumstances for an additional 15 days), and subject to customary requirements included in the agreement, enter into or recommend a transaction with a person or group that makes a superior proposal. There can be no assurance that this process will result in a superior proposal. Cambrex does not intend to disclose developments during this process unless and until the Board makes a decision with respect to any superior proposal it may receive.

Morgan Stanley & Co. LLC is acting as exclusive financial advisor and Kirkland & Ellis, LLP is serving as legal advisor to Cambrex. RBC Capital Markets is acting as exclusive financial advisor and provided committed debt financing to the Permira funds and Skadden, Arps, Slate, Meagher & Flom, LLP is serving as legal advisor to the Permira funds.

AMAG PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

On August 7, 2019 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the second quarter ended June 30, 2019 and provided a business update (Press release, AMAG Pharmaceuticals, AUG 7, 2019, View Source [SID1234538370]).

"We are pleased to report both year-over-year and sequential revenue and market share growth in the quarter for each of our key commercial products – Makena subcutaneous (SC) auto-injector, Feraheme and Intrarosa. This strong, consistent execution by our commercial team positions us well for next month’s launch of Vyleesi, our fourth commercial product," said William Heiden, AMAG’s president and chief executive officer. "Despite the strong commercial success of our promoted products, we have lowered our 2019 financial guidance to reflect the impact of Makena intramuscular (IM) supply issues and our changed expectations of milestone payments due to us from a development partner related to ciraparantag."
KEY UPDATES

Makena supply: due to sustained supply disruptions, resulting in loss of market share, and increased generic competition, the company made the decision to exit the IM market and, through mutual agreement, has terminated the arrangement with Prasco, LLC, its authorized generic partner.

Makena PROLONG study: in a recent meeting with the U.S. Food and Drug Administration (FDA) regarding PROLONG, the Agency informed the company that it plans to hold an Advisory Committee meeting. This meeting is expected to occur in the fourth quarter of 2019 to facilitate transparent discussions of the PROLONG trial and allow FDA to obtain the necessary input from Advisory Committee members and important stakeholders to inform regulatory decision-making for Makena. In addition to presentations by the company and the FDA, clinical experts, medical society representatives and patients will have the opportunity to provide their perspectives on the clinical importance and medical need for Makena.

Quarterly growth across all promoted products: strong revenue and market share performance in the second quarter

Makena (hydroxyprogesterone caproate (HPC) injection) SC auto-injector achieved 63% market share of all FDA-approved HPC prescription volume in the quarter.

Feraheme (ferumoxytol injection) achieved record market share of 17.2% in the quarter.

Intrarosa (prasterone) exited the quarter at a TRx share of 4.8%, the highest share achievement since launch.

VyleesiTM (bremelanotide injection) on track for national launch in September: June 21 approval generated coverage from more than 300 news outlets across the country, which has helped drive early awareness of Vyleesi alongside the initial marketing campaign.

Development pipeline is progressing: the company expects to initiate a phase 3a study of ciraparantag in the fourth quarter of 2019. AMAG-423 Phase 2b/3a study continues to open new sites and enroll patients.

1 See summaries of GAAP to non-GAAP adjustments at the conclusion of this press release.

COMMERCIAL PRODUCTS AND DEVELOPMENT PROGRAM UPDATES
Makena
The Makena SC auto-injector was launched in March 2018 and has continued to grow and increase its market share every quarter since launch. Second quarter 2019 revenues increased to $41.0 million, or 8.5%, over the first quarter of 2019. Market share grew 9 percentage points to 63%, compared with 54% in the first quarter of 2019. With no intramuscular product shipped, the $10.0 million of negative revenue for the Makena IM product, for the three months ended June 30, 2019, was the result of changes in estimated Medicaid and commercial liability obligations from prior periods.

As previously disclosed, AMAG’s primary third-party manufacturer failed to timely deliver Makena IM drug product to AMAG, which led to supply disruptions and ultimately an out-of-stock situation. These supply issues hindered AMAG’s ability to provide Makena IM product, which caused Prasco to lose significant market share. Although AMAG received notice of approval from the FDA of an additional manufacturing site for the Makena IM product late in the second quarter, AMAG and Prasco concluded that it was no longer commercially viable to recapture sufficient market share following the out-of stock situation. As such, AMAG made the decision to exit the generic IM market and reached a mutual agreement with Prasco to terminate their distribution and supply agreement on August 6, 2019.

Accordingly, the company recorded a $77.4 million non-cash charge to fully write-off the intangible asset associated with the IM form of Makena and an inventory write-down of $4.8 million. In addition, the company revised its full-year 2019 financial guidance.

Vyleesi
As previously reported, on June 21, 2019 the FDA approved Vyleesi, a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The Vyleesi autoinjector is the first treatment for this patient population that can be self-administered as needed in anticipation of sexual activity. HSDD is characterized by low sexual desire that causes distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. AMAG is committed to working with payers and healthcare professionals to help ensure that women with HSDD have access to Vyleesi, as well as minimizing the cost burden to patients through a comprehensive copay assistance program. AMAG plans to launch Vyleesi nationally in September with approximately 125 sales representatives on the company’s women’s and maternal health salesforce who will be calling on an estimated 15,000 healthcare professionals.

Ciraparantag, which has been granted fast track designation by the FDA, is in development as a single-dose, ready-to-use solution for use in patients treated with novel oral anticoagulants (NOACs) or low molecular weight heparin (LMWH) when reversal of the anticoagulant effect is needed for emergency surgery or serious uncontrolled bleeding. AMAG and Perosphere Technologies (an independent company) recently met with the FDA and Perosphere Technologies is preparing to submit an investigational device exemption (IDE) to enable the use of the automated coagulometer in a Phase 3a clinical study, which AMAG expects to begin in the fourth quarter of 2019. Separately, AMAG was recently informed by a development partner for ciraparantag of its intention to terminate the existing collaboration agreement. Although AMAG does not believe that this partner has grounds for termination, it has removed expected milestone payments from its 2019 financial guidance.

UPDATED 2019 FINANCIAL GUIDANCE
"Although our commercial teams delivered strong results for our promoted products, we are lowering our 2019 financial guidance because we exited the Makena IM market and revised our expectation of ciraparantag development milestone revenue. The changes to our 2019 guidance do not alter our previously-stated preliminary view that we will achieve neutral adjusted EBITDA in 2020," said Ted Myles, AMAG’s chief financial officer. "With strong cash flows from our commercial products and our flexible cost structure, we believe we are well positioned to bring innovative therapies to patients in need and to build a new chapter of durable growth for shareholders. Our updated guidance and our preliminary view of an adjusted EBITDA-neutral 2020 reflects continued strong commercial performance from Makena SC auto-injector, Feraheme and Intrarosa, and includes a fully-funded launch of Vyleesi and our clinical development plans for AMAG-423 and ciraparantag."

2019 Financial Guidance

2 See reconciliations of 2019 GAAP to non-GAAP financial guidance at conclusion of this press release.

SECOND QUARTER ENDED JUNE 30
Revenue
Growth of the company’s key marketed products continued in the second quarter, with strong revenue and market share performance.

Makena SC auto-injector revenue grew to $41.0 million, compared with $13.5 million in the same period last year (launched March 2018).

The company did not ship any Makena IM product during the quarter, therefore the full impact of the $10.0 million change in estimated Medicaid and commercial rebate liabilities from prior period sales appears as negative revenue during the quarter.

Feraheme revenue increased to $42.1 million, an increase of 12% over the same period last year. Feraheme’s average quarterly market share increased to 17.2%, compared with 16.3% in the same period last year and 16.1% in the first quarter of 2019.

Intrarosa revenue totaled $4.9 million, compared with $3.2 million in the same period last year. TRx share increased to 4.5%, compared with 3.2% in the same period last year and 3.9% in the first quarter of 2019.

Operating Expenses

Cost of products sales (CoPS) in the second quarter of 2019 included a $4.8 million write-down of Makena IM inventory; CoPS in the second quarter of 2018 included $61.4 million in amortization expense primarily related to the Makena IM intangible asset.

Selling, general and administrative (SG&A) expenses in the second quarter of 2018 included an expense reversal of $49.8 million related to the Makena contingent consideration liability because the company no longer believed that it was probable that a sales milestone would be achieved. Excluding this expense reversal, SG&A expenses increased by $11.6 million, or 18%, in the second quarter of 2019, compared with the same period last year, primarily due to increased marketing expenses related to the upcoming launch of Vyleesi.

The intangible asset impairment charge relates to the full impairment of the Makena IM intangible asset (described above).

As of June 30, 2019, the company’s cash and investments totaled $261.0 million.

The FDA approval of Vyleesi triggered a $60.0 million payment obligation to Palatin Technologies, which was paid in July 2019.

Long-term debt totaled $320.0 million (representing the principal amounts outstanding of the 2022 convertible notes).

Operating Loss and Adjusted EBITDA

The impact of the $77.4 million non-cash impairment charge and the related $4.8 million inventory write-down in the second quarter of 2019 contributed to an operating loss of $115.8 million. The company reported negative adjusted EBITDA of $24.4 million in the second quarter of 2019.

CONFERENCE CALL AND WEBCAST ACCESS
AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss the company’s second quarter 2019 financial results, recent business highlights and 2019 outlook.

DIAL-IN NUMBER
U.S./Canada Dial-in Number: (877) 412-6083
International Dial-in Number: (702) 495-1202
Conference ID: 8573359

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 8573359

A telephone replay will be available from approximately 11:00 a.m. ET on August 7, 2019 through midnight on August 14, 2019.

The webcast with slides will be accessible through the Investors section of the company’s website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.