juniper pharmaceuticals, inc. (jnp)

by:Keyuan     2020-06-17
☒Annual Report submitted under Section 13 or 15 (d)
1934 Securities Trading Act☐Transition reports submitted under sections 13 or 15 (d)
1934 Securities Trading Act☐☐☒☒☐☒☐☐Table 10-Index of annual reports
Kpartibusiness risk factors address the security disclosure market for employee reviews property legal procedures registrant common stock, related shareholder matters of stock securities and the purchase of selected financial data by the issuer management of the company\'s discussion and analysis of financial status and operational results quantitative and qualitative disclosure of financial statements and supplementary data on market risks in accounting director of financial disclosure control and procedures, other information, executive officers and corporate governance administrative compensation, secured ownership, director independent chief accountant fees and services ivitem15 exhibits and schedule of financial statements for certain beneficial owners and management and related shareholders
View information IItem 1.
Businesssin vivoin vivocinone is a 8% progesterone bio-Adhesive Vaginal gel for progesterone supplement or replacement as part of the artistic treatment of women who lack infertility with progesterone as well as many other countries in the world.
Crinone is the main source of our business income.
We have licensed Crinone to our business partner Merck KGaA, for all markets outside the US, and we range from manufacturing and selling Crinone to international markets in Merck KGaAWe sold the U. S.
In 2010, Crinone\'s intellectual property rights to Allergan and received royalties from Allergan based on its United StatesS.
Sales until October 2016.
In November 2016, we entered into an agreement with Allergan to monetize future royalties payable to us.
According to the agreement, we received one. time non-
A refundable payment of $11.
In exchange, Allergan will no longer have to pay us future royalties. JNP-
0101 is a candidate for an IVR product designed to provide oxifbening for the treatment of overactive bladder (“OAB”)in women.
Oxibuning is currently approved for the treatment of overactive bladder, however, patients often stop oral oxibuning treatment due to adverse side effects, including dry mouth, blurred vision and constipation.
We expect that the delivery of orxibuning using our IVR technology will provide better side effects as the drug will bypass the liver metabolic problems that first pass.
In the case of orxibuning, the drug is metabolized into active metabolites in the liver, resulting in an increase in the central nervous system (“CNS”)side effects.
In addition, compared to other route of administration, we believe that delivery using our IVR technology will improve patient compliance and convenience, including oral therapy, patch and gel.
We have completed our pre-clinical animal studies and expect to finalize the results of these studies for our IVR project, which was developed by JNP-0101, JNP-0201 and JNP-0301 (
\"IVR Project \")
First half of 2018.
Before the final results of these studies come out, we plan to find a partner for our JNP
0101 of product candidates, standing-
Individually or in combination with one or more of our other IVR project candidates. JNP-
02011 is a candidate for segmented IVR products containing natural progesterone and natural estrogen for hormone replacement therapy in menopausal women. JNP-
0201 was designed to deliver natural hormones locally to vaginal tissue.
This is another example of avoiding first pass, and liver metabolism of estrogen may lead to an improvement in side effectseffect profile.
We also believe that our mode of delivery will improve the beneficial effect of estrogen compared to the currently approved combination hormone replacement therapy;
These include oral preparations using synthetic progesterone, which have been considered to have a higher risk of side effects including cardiovascular events in open clinical trials.
In addition, compared to other route of administration, we believe that delivery using our IVR technique will improve patient compliance and convenience, including oral therapy and patch.
We have completed our pre-clinical animal studies and expect to finalize the results of these studies for our IVR project, which was developed by JNP-0101, JNP-0201 and JNP-0301 (
\"IVR Project \")
First half of 2018.
Before the final results of these studies, we may be looking for a partner for our JNP
0201 of product candidates, standing-
Individually or in combination with one or more of our other IVR project candidates. JNP-
0301 is a candidate for natural progesterone IVR products to prevent premature delivery (“PTB”)
Women with short cervical length.
Short length of Middle cervical spine
Pregnancy is an important predictor of premature delivery in women.
Medical guidelines issued by the American College of Gynecologists and maternal fetal medicine, among other things, support the use of vaginal progesterone in women with shorter cervical length
Pregnancy reduces the risk of PTB.
FDA has not approved treatment to prevent PTB in women at risk due to short cervix. We believe JNP-
0301 can achieve continuous local delivery of progesterone while promoting patient compliance.
We have completed our pre-clinical animal studies and expect to finalize the results of these studies for our IVR project, which was developed by JNP-0101, JNP-0201 and JNP-0301 (
\"IVR Project \")
First half of 2018.
Before the final results of these studies come out, we plan to find a partner for our JNP
0301 of product candidates, standing-
Individually or in combination with one or more of our other IVR project candidates.
We offer Crinone\'s strategy to our business partner Merck KGaA for sales in more than 90 countries around the world;
Get more and more revenue from our recipe, analysis and product development capabilities in JPS and have the possibility to deploy these same capabilities to improve our in-
Product candidates;
And complete our vivopreclinical animal research results for our IVR project in the first half of 2018 with the goal of finding one or more partners for our IVR product candidate or IVR platform
Identified for our IVR as well as pre-clinical and clinical studies, including a study by Kimball et al, published in the controlled release journal in May 2016, has demonstrated its ability to deliver larger-sized peptides
In vivoIn on November 2016, we reached an agreement with Allergan to monetize future royalties payable to us.
According to the agreement, we received one. time non-
A refundable payment of $11.
In exchange, Allergan will no longer have to pay us future royalties.
In these studies, it was found that the delivery of oxibuning provided
Monthly treatment plan.
The sponsor, however, did not bring the assessed molded silicone oxifbunin IVR to market, as it decided to withdraw from women\'s health.
Prevention of PTB treatment in women
Due to the risk of short cervix. We believe JNP-
0301 it is possible to make continuous local delivery of progesterone improve patient compliance.
We plan to use the third one.
Contract manufacturers for the clinical supply and commercial manufacture of these product candidates.
2 medical grade, medical grade, Cross
Polymer used in our BDS-
Crinone-based products are currently available only from one supplier, Lubrizol. (“Lubrizol”).
We believe Lubrizol will provide as much material as we need, as our products rank first in the highest value
Additional use of polymers.
However, if Lubrizol cannot or will not provide enough carbohydrates to meet our needs, we will be asked to find alternative sources of supply. (
Oral microtiter of progesterone)
Sold by Abbott Labs and Endometrin®(
Progesterone vaginal insert)
Sold by Ferin Pharmaceutical
Since 2013, the FDA has
The FDA has approved a combination therapy provided by a compound pharmacy and commonly known as a \"bioidentical\" drug. These non-
It is difficult for the FDA to measure and monitor approved drugs, which leads to concerns about safe use. JNP-
If approved, an alternative combination treatment will be provided at 0201.
FDA\'s biggest competitor
Pfizer and Pirelli (
Combined Estrogen)and Prempro (
Combined estrogen/progesterone acetate tablets)
Malan, bar (
Estrogen)and Noven (minivelle)
, Selling Prempro\'s leading combination therapy for hormone replacement therapy in menopausal women.
In 1995, the FDA approved the use of women with uterine integrity for the treatment of moderate to severe vascular contraction symptoms and/or vulvar and vaginal atrophy caused by menopause to prevent post-menstrual osteoporosis.
Under the terms of our current licensing and supply agreement with Merck KGaA, we will sell Crinone-to Merck KGaA in one country-by-
A larger national base (i)
Direct manufacturing costs plus 20% or (ii)
The percentage of net selling price of Merck KGaA by hierarchical structure.
In addition, we work with Merck KGaA to evaluate and implement measures to reduce manufacturing costs, and the parties share any benefits of these initiatives.
This agreement requires Merck KGaA to provide 18-
Monthly forecast of Crinone demand in each country where the product is sold.
The first four months of each forecast are considered fixed orders.
Under the agreement, it is the responsibility of each party to carry out new clinical trials and government registrations on its territory, and the parties are obliged to consult from time to time on these studies.
Both parties agree to immediately provide the other party with data from its Crinone study free of chargeof-charge.
Within the term of the agreement, we agree not to develop, license, manufacture or sell to another party other than the United States for any product used for vaginal delivery of progesterone or pregnancy promotion agents, indications for hormone replacement therapy or other commonly used progesterone or pregnancy promotion agents.
In the United States, the FDA manages drugs under the Federal Food, Drug and Cosmetics Act (“FDCA”)
And its implementation regulations.
Drugs are also subject to other federal, state and local regulations and regulations.
The process of obtaining regulatory approval and subsequent compliance with applicable federal, state, local and foreign regulations and regulations requires significant time and financial resources.
Failure to comply with applicable US lawS.
At any time after the product development process, approval process or approval, the requirement may impose administrative or judicial sanctions on the applicant.
These sanctions may include, among other actions, FDA\'s refusal to apply for approval, withdrawal of approval, clinical holding, untitled or warning letter, voluntary product recall or withdrawal from the market, product seizure, suspension of production or distribution in whole or in part, prohibition, fine, refusal of government contract, return, return or civil or criminal penalty.
Any agency or judicial enforcement action can have a significant adverse impact on us.
Complete a wide range of non-clinical laboratory tests, animal studies, and preparation studies in accordance with applicable regulations, including FDA Good Laboratory specifications (“GLP”)regulations;
The FDA submitted to IND must take effect before the human clinical trial begins;
Full and good performance
Controlled human clinical trials conducted in accordance with applicable IND and other clinical research-related regulations, called Good Clinical Practice (“GCPs”)
Determine the safety and effectiveness of the proposed drug for its proposed indications;
Submit a non-disclosure agreement to the FDA;
FDA decides to submit a non-disclosure agreement for review within 60 days of receipt of the non-disclosure agreement;
Satisfactory completion of FDA pre-
Approve the inspection of manufacturing facilities or facilities for the production of drugs to assess whether they conform to FDA cGMP to ensure that facilities, methods and controls are sufficient to preserve the identity of the drug, strength, quality, purity;
FDA\'s potential audit of clinical trial sites where NDA data is generated;
Fda reviews and approves NDA before conducting any commercial marketing or sales in the US.
IND automatically takes effect within 30 days of FDA receipt, unless FDA is at 30-
Within one day, notify the applicant of safety issues or issues related to one or more of the proposed clinical trials and place the trials in clinical shelved status.
In this case, IND sponsors and FDA must resolve any outstanding issues before the start of the clinical trial.
Due to safety issues or non-compliance, the FDA may also implement a clinical suspension before or at any time during the trial.
Therefore, submitting an IND may not result in an FDA authorization to start a clinical trial.
Phase 1-initially conducted studies in healthy human volunteers or subjects with a target disease or disease and tested the safety, dose tolerance, structure of the study drug
Activity Relationship, mechanism of action, absorption, metabolism, distribution and excretion.
If possible, the first phase of clinical trials can also be used to obtain early evidence of effectiveness.
A phase 2 controlled study was conducted in a limited population of subjects with a specific disease or condition to assess the initial efficacy, determine the optimal dose, dose tolerance and schedule, possible adverse effects and safety risks.
Stage 3-these are enough and good
Conduct controlled clinical trials in an expanded subject population, usually at geographically dispersed clinical trial sites, to generate sufficient data to provide evidence of the clinical efficacy and safety of the product for approval, build overall risk-
Overview of the benefits of the product and provide sufficient information for the label of the product.
Usually, two Phase 3 clinical trials are required by the FDA to obtain product approval.
Contains data sufficient to assess the safety and efficacy of the drug in all related pediatric groups claiming indications, and supports the dose and administration of each pediatric group for which the product is safe and effective.
FDA may, on its own initiative or at the request of the applicant, approve the postponement of the submission of some or all pediatric data until the approval of the product for use in adults or the complete or partial waiver of pediatric data requirements.
The FDA may also need to submit risk assessment and mitigation strategies (“REMS”)
Ensure that the benefits of the drug outweigh the risks of the drug.
The REMS program can include medication guidelines, physician communication plans, and elements that ensure safe use, such as restricted distribution methods, patient registration, or other risk-minimizing tools.
REMS must also be evaluated at set intervals.
If new safety information is found after product approval, the FDA may also need REMS, and the FDA determines that REMS are necessary to ensure that the benefits of the drug are greater than the risk of the drug.
The applicant may resubmit the NDA to address all defects found in the letter;
Withdraw the application;
Or request an opportunity for a hearing.
The CRL indicates that the review cycle of the application has been completed, that the application is not ready for approval, and describes all the specific defects found by the FDA in theNDA.
CRL generally contains statements of specific conditions that must be met in order to obtain the final approval of the NDA, and in order for the FDA to reconsider the application, additional clinical or non-clinical tests may be required.
Defects may be small, for example, label changes are required or additional clinical trials are required.
The FDA\'s goal is to review 90% of applications for resubmission within two to six months of the resubmission date, depending on the type of resubmission.
Even if these additional information is submitted, the FDA may ultimately decide that the application does not meet the regulatory standards approved.
If these conditions have reached the satisfaction of the FDA, the FDA may issue an approval letter.
The letter of approval authorizes the commercial marketing of the drug and provides specific prescription information for specific indications.
During the same time as the innovative drug, the active ingredient enters the subject\'s blood, and the pharmacist can usually be replaced by a prescription for the reference listed drug.
The approval of the application shall be carried out or sponsored by the applicant. This three-
The annual exclusivity period prevents FDA approval of ANDAs and 505 (b)(2)
NDAs for new drug approval conditions.
All in all, these three
FDA approval of ANDAs or 505 is not prohibited exclusively for the year (b)(2)
The original NDAs of generic drugs that have not been modified. Five-year and three-
Annual exclusivity will also not delay the submission or approval of a complete NDA;
However, applicants who submit a complete NDA will be required to conduct or obtain the right of reference to all non-clinical studies, as well as full and good
A controlled clinical trial necessary to demonstrate safety and efficacy.
In addition, even if the product is granted a period of exclusivity, doctors can prescribe generic drugs that refer to listed drugs or refer to listed drugs in the following cases
Label for the same use as the newly approved drug.
Act, not participating in the federal health care program, mandatory compliance program under the corporate integrity agreement, disqualifying and refusing government contracts.
A product consisting of two or more regulated components that are physically, chemically or otherwise combined or mixed and produced as a single entity;
Two or more products individually packaged together, or products packaged together as a unit, consisting of drug and device products, device and biological products or biological and drug products;
Individually packaged drugs, devices, or biological products, subject to their research plan or proposed labeling, are for use only with individual approval
A specific drug, device, or biological product, both of which need to achieve the intended use, indication, or effect, and need to change the label of the approved product after approval of the proposed product, E. G. g.
, Reflecting changes in the intended use, dosage form, intensity, route of administration, or significant changes in dose;
Or any research drug, device, or biological product individually packaged under its proposed label is only used for another research drug, device, or biological product designated separately, both need to achieve the intended use, indication, or effect.
Reimbursement rate.
Therefore, the coverage determination process will require us to provide scientific and clinical support for the individual use of our products by each payer, which will be a time --
Consumption process.
Arrange or recommend the purchase, lease or order of any goods, facilities, items or services that can be paid in whole or in part, such as Medicare or Medicaid, under the federal health care program.
The term \"remuneration\" is widely interpreted as including anything of value.
Rebate regulations are interpreted as applicable on the one hand to pharmaceutical manufacturers and on the other hand to arrangements between prescribing, purchasers and prescription administrators.
Despite some statutory exceptions and the regulation of safe ports to protect some common activities from prosecution, the scope of exceptions and security is narrow.
Practices involving remuneration may be alleged to be intended to induce prescriptions, purchases or suggestions and may be subject to review if they do not qualify for an exception or safe harbor.
Failure to meet all the requirements of a particular applicable statutory exception or regulation of a safe harbor would not make the act itself
Rebate regulations.
Instead, the legitimacy of the arrangement will be assessed in one caseby-
Based on the case base of the cumulative review of all its facts and circumstances.
In addition, the standard of intent under federal anti-corruption
The law on Patient Protection and Affordable Care amends the rebate regulations and is amended by the health care education and Reconciliation Act of 2010 (
\"Affordable Health Care Act \")
The more stringent criterion is that a person or entity no longer needs to actually understand the regulations or the specific intentions of violating them in order to violate them.
In addition, the affordable medical Act codifies case law, stipulating that claims include violations of federal
For the purposes of the federal False Claims Act, the rebate regulations constitute false or fraudulent claims.
Violations of this law will be subject to imprisonment of up to five years, criminal penalties, administrative civil penalties and exclusion from federal health care programs.
In addition, many states have passed similar
Rebate regulations.
Some of these state bans apply to patient referrals for health care services reimbursed by any insurance company, not just federal health care programs such as Medicare and Medicaid.
Due to widespread federal opposition
Rebate laws, and the possibility of additional legal or regulatory changes in this area, our future business activities are possible, including our sales and marketing practices and/or our future relationships with healthcare providers may be counter-tested
Could hurt our kickbacks.
Material false, fictitious or fraudulent statements relating to the delivery or payment of medical benefits, programs or services.
Failure to comply with applicable regulatory requirements leaves us subject to possible legal or regulatory actions.
According to the specific circumstances, failure to meet the applicable regulatory requirements may result in significant criminal, civil and/or administrative penalties, damages, fines, removal, exclusion from federal health care programs such as health insurance and medical care subsidies, bans, voluntary recall or seizure of products, suspension of production in whole or in part, rejection or revocation of product approval, refusing to allow us to enter into supply contracts, including government contracts, contract damage, reputation damage, administrative burden, profit reduction and future revenue, reduction or restructuring of our business, any of these may adversely affect our ability to operate our business and the results of our operations.
Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and enter into a national rebate agreement with the Minister of Health and Human Services in exchange for medicines from manufacturers of Medicaid coverage in most countries
The Affordable Care Act has made several changes to Medicaid Drug Rebate programs, including increasing pharmaceutical manufacturers by raising minimum basic Medicaid rebates to £ 23 for prescription drugs for most brands
1% of the average manufacturer\'s price (“AMP”)
And add a new rebate calculation for \"line extension (i. e.
New preparations, such as slow-release preparations)
Solid oral dosage form for branded products, as well as its rebate liability may be affected by modifying the legal definition of AMP
The Affordable Care Act expands the type of entity eligible for a discount of 340B pricing.
In addition, since the 340B pricing is determined based on AMP and Medicaid Drug Rebate data, revisions to the aforementioned Medicaid rebate formula and AMP definitions may result in an increase in the required 340B discount.
The Affordable Care Act requires branded drug manufacturers to offer a 50% discount on the negotiated price of branded drugs distributed to Medicare Part D beneficiaries in the insurance gap (i. e. , “donut hole”).
The Affordable Care Act imposes annual non-deductible fees on any entity that produces or imports certain branded prescription drugs, which are distributed on the basis of its market share in certain government health care programs
The Affordable Health Care Act creates a new patient.
Focus on the results Institute, supervise, prioritize, conduct comparative clinical effectiveness studies, and fund such studies.
Research conducted by patients-
Results-centric research institutions may affect the market for certain drugs.
The Affordable Care Act creates an Independent Payment Advisory Board that has the authority to recommend certain modifications to the Medicare plan to reduce the expenditure that the plan may result in a reduction in prescription drug payments.
In some cases, these proposals will become law, unless legislation is enacted by Congress to achieve the same or greater cost savings in medical insurance.
The Affordable Health Care Act has set up a medical insurance and Medicaid Innovation Center within CMS to test innovative payment and service delivery models to reduce Medicare and Medicaid spending,
As of 2019, funds had been used to support the mission of the Center for Innovation in Medicare and Medicaid.
As of December 31, 2017, revenue in our product sector was $2016 and $2015 respectively. 7 million, $41.
$5 million and $26.
6 million respectively.
As of December 31, 2017, revenue from our services was $2016 and $2015 respectively. 3 million, $13.
$1 million and $11.
7 million respectively. www. juniperpharma. comir. juniperpharma.
ComWe issued business conduct and ethics applicable to all employees in the \"corporate governance\" subsidiary, including all senior executives, senior financial officers and directors
Section on \"Investor Relations (ir. juniperpharma. com)
Website of our company websitejuniperpharma. com.
Our business conduct and ethics comply with 406th SEC regulations
And the rules of Nasdaq.
We intend to disclose any changes to the code that affect the provisions of S-regulation 406th
K, and any exemptions on our company\'s website for the code of ethics for executives, senior finance officers or directors. Item1A.
Risk factors if, at the end of the supply term, the parties cannot reach a mutually acceptable clause on the extension of the supply arrangement, Merck KGaA will have the option to negotiate the purchase of all our assets related to the Crinone supply chain, and transfer manufacturing to the management of third-party or product supply.
Foreign governments often impose strict controls on prices, which may adversely affect our future profitability. .
State or conduct regular public disclosure of sales, marketing, pricing, clinical trials and other activities.
In addition, as part of the Affordable Care Act, drug manufacturers must publicly report on gifts and other payments or value transfers paid to the United StatesS.
Doctors and teaching hospitals.
Some states have also passed laws banning certain marketing.
Related activities include the provision of gifts, meals or other items to certain health care providers.
Many of these requirements are new and uncertain, and the extent to which penalties for failure to comply with them may not be clear;
However, compliance with these laws is difficult, time-consuming and expensive, and we may face enforcement actions, fines and other penalties if we are found to have not fully complied with them, we can accept unfavorable publicity, which may adversely affect our business, our financial situation, and the results of our operations.
We need to develop our organization and we may have difficulties managing this growth, which may undermine our operations.
Or seek potential partners for commercialisation related to clinical development, regulatory review, approval and commercialisation of our product candidates cannot generate sufficient pre-clinical or other in-vivo or in-vitro data to support the start of clinical trials;
Delay in reaching consensus with regulators on research design;
FDA does not allow us to rely on previous findings of the safety and effectiveness of other similar but approved products and published scientific literature. .
Delay the commencement of the trial with regulatory approval;
Implementation of a clinical suspension after the FDA or other regulatory body has examined the clinical trial operation or trial site of our or our potential partners;
Enforcement of clinical suspension due to safety or effectiveness issues with the data and security monitoring board or DSMB, FDA or institutional review board, IRB or usor our potential partners;
Due to major problems with product candidates at the same level as one of our product candidates, FDA or other regulatory authorities force clinical holding;
An agreement with a potential contract research organization on acceptable terms (“CROs”)
And the place of trial, whose terms can be negotiated extensively, and there may be significant differences between different Croatia and the place of trial, especially in foreign jurisdictions;
Delays in obtaining the required IRB approval at each location;
Delays in identifying, recruiting and training suitable clinical researchers;
The recruitment rate of patients was lower than expected due to narrow screening requirements;
Patients are unable to meet the requirements of the agreement imposed by the FDA or other regulatory authorities;
Unable to retain patients who have started to participate in clinical trials but may be easily withdrawn due to various clinical or personal reasons, or who have lost further follow-upup;
Patient delay after full participation in the trial or return
Treatment trackingup;
Patients cannot be fully observed after treatment;
Exit trial of clinical site, damage registration;
Time required to add a site;
According to the current good manufacturing specifications, it is not possible to manufacture a sufficient number of qualified materials (“cGMPs”)
For clinical trials;
Shortage of active drug ingredients (“API”); non-
Compliance with regulatory requirements;
Delay in obtaining adequate clinical trial materials, including appropriate APIs;
The need or desire to modify the manufacturing process;
Changes in regulatory requirements for clinical trials;
Lack of effectiveness in clinical trials;
Unforeseen safety issues or adverse drug reactions;
As IRB is responsible for supervising the study at a particular research site, the delay, suspension or termination of clinical trials;
Insufficient financial resources;
Government or regulatory agencies that require the suspension or termination of trials to delay or \"clinical hold \";
And the delay caused by DSMB\'s negative or ambiguous findings of the trial.
Any of these delays in completing the clinical trials of our potential partners can increase costs, slow down the product development and approval process, and jeopardize our or our potential partners ability to start product sales and generate revenue
Or the patient qualification criteria defined in the agreement of our potential partner;
Analyze the size and nature of the patient population required for the primary end point of the trial;
The distance from the patient to the research site;
Design of the trial;
Our ability to recruit clinical trial researchers with appropriate capabilities and experience;
Ability to obtain and maintain patient consent;
The risk of patients participating in clinical trials exiting the trial before completion;
Compete for other competitive treatments for patients through clinical trials;
In addition, clinicians and patients view the potential advantages of the drugs being studied relative to other available therapies, including any new drugs that we or our potential partners are investigating that may be approved for indications.
Or any of these proposed products from our potential partners, or our potential partner partners, will be postponed or canceled.
Any one of these events can seriously damage our business, our financial position, our results and prospects.
Or our potential partners must submit new or complementary applications and obtain FDA approval for certain changes to approved products, product labels or manufacturing processes.
The applicant holder must also submit advertising and other promotional materials to the FDA and report on ongoing clinical trials.
Legal requirements have also been issued for disclosure of clinical trial results on an open database.
Or our potential partners investigate the fraud of us or our potential partners and any suspected violations;
Issue a warning letter or Untitled letter claiming that our potential partners have violated the law;
Seek a ban or impose a civil or criminal penalty or fine;
Suspension or revocation of regulatory approvals;
Require our potential partners to suspend or terminate any ongoing clinical trials;
Refusal to approve pending applications or supplementary applications submitted by the United States or our potential partners;
Suspension or restriction of operations, including expensive new manufacturing requirements;
Seizure or withholding of products, refusal to allow import and export of products, or request a product recall from our potential partners;
Or exclude our potential partners from providing our products to people involved in government health care programs such as Medicare and Medicaid, and refusing to allow us or our potential partners to sign supply contracts,
Or our potential partners, or our potential partners, the manufacture and packaging of drugs must comply with the requirements of the FDA and similar foreign regulatory authorities.
If we, or our third
Our product development and business efforts can be compromised.
Any new instructions (s)
Section 505th (b)(2)
Applicants for additional data support.
However, the label may need to list all or part of the restrictions, taboos, warnings or precautions contained in the drug label, including black box warnings, or additional restrictions, taboos, warnings or precautions may be required.
The clinical indications (if any) approved for our product candidates );
It is safe and effective for doctors and payers to receive each product;
The cost of treatment related to alternative treatment, including many generic products;
Our products are relatively convenient and easy to treat their expected symptoms;
Supply and efficacy of competitive and generic drugs;
Effectiveness of our sales team and marketing work;
The extent to which the product is approved for inclusion in the prescription set of hospitals and managed care organizations;
Third-party or government health care programs such as insurance companies and other medical payers (including medical insurance and Medicaid) provide insurance and appropriate reimbursement;
Restrictions or warnings contained in the product FDA-
Recognition label;
Incidence and severity of adverse side effects.
Or our potential partner research program to identify new disease targets or conditions, and product candidates, whether or not we finalize any additional product candidates, will require a significant amount of technical, financial and
Our research program may initially demonstrate commitment in identifying potential product candidates, but for multiple reasons we have failed to produce product candidates for clinical development, including: the research methods used may not be able to successfully identify potential product candidates;
Alternatively, potential candidate products may prove to have harmful side effects or other features that suggest that they are less likely to be effective drugs in further studies. . .
An unforeseen way or an unforeseen queue.
If any product or product developed or commercialized by us or our potential partners in the future proves to be harmful, or generates negative publicity from adverse events, our business, financial situation, the results and prospects of the action will be materially compromised.
Identify and develop product candidates that are superior to other products on the market;
Obtaining approval from the regulatory authorities;
Fully convey the benefits of our product candidates if approved;
Attracting and retaining qualified personnel;
Obtaining and maintaining patents and/or other proprietary protection for our product candidates and any future product candidates we may develop;
And get collaborative arrangements to commercialize our product candidates and any future product candidates we may develop. .
Mandatory rebates for drugs sold in Medicaid programs have increased and rebate requirements have been extended to drugs used at risk
Medical programs managed by Medicaid.
For reporting purposes, the definition of \"average manufacturer price\" has been revised, which may increase the amount of state Medicaid drug rebates.
Under the Public Health Services Act, the 340B Drug Pricing Program has been expanded to require discounts on drugs sold to certain key access hospitals, cancer hospitals and other covered entities.
Brand discount must be offered by pharmaceutical companies-
Name the drug as a patient who is within the reach of the Medicare part d coverage, often referred to as the \"donut hole \".
\"Pharmaceutical companies need to pay non-Annual
According to the market share of each company in the total sales of certain federal health care project brand products in the previous year, the federal government is charged a tax exemption fee.
Aggregation industry-
It is expected that by 2019, the total cost will reach $28 billion.
As we expect our branded drug sales to account for a fraction of the federal health care program drug market, we do not expect this annual assessment to have a significant impact on our financial position.
In California, October 25, 2017
In addition, CMS has recently proposed regulations that give states greater flexibility in setting benchmarks for insurers in individual and small-group markets, this may ease the basic health benefits that ACA needs to sell through these markets.
Congress may consider other legislation to replace the components of the ACA.
In addition, on January 20, 2017, President Trump signed an executive order directing federal agencies that have authority and responsibility under the Affordable Care Act to waive, postpone, approve exemptions, or delay the implementation of any provisions of the Affordable Care Act, which will impose financial burdens or costs on the state, fees, taxes, fines or regulatory burdens for individuals, healthcare providers, health insurance companies or manufacturers of medicines or medical devices.
Congress could also consider subsequent legislation to replace the content of the abolished Affordable Care Act.
Therefore, the full impact of the affordable medical bill, any laws that replace the elements of the bill, and the political uncertainty of abolishing or replacing the bill on our business remain unclear.
Risks related to our reliance on third parties we rely entirely on third parties to make our commercial products, we use a single
The source suppliers of some of our raw materials, as well as any difficulties, interruptions or delays, or the need to find alternative sources, can adversely affect our profitability and future business prospects.
Unexpected demand or shortage of raw materials or other materials;
Supplier or adverse financial development affecting supplier;
Regulatory requirements or actions;
Timely dispatch and/or sufficient capacity cannot be provided;
Difficulties in manufacturing;
Changes to the specifications of raw materials so that they no longer meet our standards;
The lack of sufficient quantity or profit to produce raw materials to interested suppliers;
Labor disputes or shortages;
Import or export issues.
If we are unable to manufacture our products and candidate products in a timely or adequate manner due to the above factors, we may not be able to meet the commercial or clinical development needs of our products and candidate products, or may not be at the cost-
Effective way.
As a result, we may lose sales, not be able to increase revenue, or suffer regulatory setbacks, any of which may adversely affect our profitability and future business prospects.
We have identified the second supplier of progesterone.
The second supplier has been approved in several countries and is in the process of regulatory approval in many other countries.
We expect that in the next two years we will receive regulatory approval from a second supplier in the country where Crinone is sold.
In vivosigniantly, our product development and commercialisation efforts have been delayed, scaled down or stopped;
Looking for collaborators for our product candidates at a stage earlier than expected, or in conditions less favourable than expected;
And licensing may be adverse to the terms of our right to our product candidates, otherwise we will seek our own development or commercialize.
Waive valuable rights to our technology, future sources of revenue, research projects or proposed products, or grant permission on terms that are not good for us.
Performance is significantly insufficient relative to historical or expected future operating results;
The manner in which assets are acquired or the manner in which they are used or the strategy of our overall business has changed significantly;
Major negative impacts on industry or economic trends;
Our stock prices continue to fall sharply;
Changes in our organization or management reporting structure may result in additional reporting units, which may require alternative methods to estimate fair value, or greater classification through reporting units in our analysis;
Our market value is below the net book value.
Risks associated with our intellectual property rights, the amount of reimbursement for our product candidates in a foreign market, and the nature of any restrictions and caps on such reimbursement;
To the extent that we rely on third parties, we have no direct control over business activities;
The burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements;
Different medical practices and customs in foreign countries affect the acceptance of the market;
Import and export licensing requirements;
The collection time of accounts receivable is long;
The transportation lead time is longer;
Language barriers to technical training;
Reduce the protection of foreign intellectual property rights;
There are other potentially related third-
Intellectual property rights of the party;
(1) fluctuations in foreign exchange rates;
And the interpretation of the contract terms governed by foreign law in the event of a contract dispute. and time-consuming.
We may not be able to file and Sue all necessary or desirable patent applications at a reasonable cost or in a timely manner.
The invention is not included in the patent claim.
In litigation or proceedings involving our patents, adverse results may limit our ability to claim patents against these parties or other competitors, and may limit or exclude our ability to exclude third parties from manufacturing and selling similar or competitive products.
Any of these events may adversely affect our competitive business position, business prospects and financial position.
If we were found guilty of a third infringement
We may be forced to stop the development, manufacture or commercialize of candidates or products for infringing products, including through court orders.
Alternatively, in order to use infringing technology and continue to develop, manufacture or market candidates for infringing products, we may need to obtain a license from that third party.
However, we may not be able to obtain any necessary permission on commercially reasonable terms or at all.
Even if we can get a license, it may not be
So our competitors can get the same technology that we license.
In addition, if we are found to be intentionally infringing the patent, we may be found to be responsible for the loss of money, including three times the loss and the cost of attorney\'s fees.
Infringement findings may prevent us from commercializing product candidates or force us to stop some business operations, which may have a significant adverse impact on our business.
Claiming that we have stolen confidential information or trade secrets from third parties.
The parties may have a similar negative impact on our business.
It is not enough to enforce our patents to prevent infringement.
These products may compete with our products, and our patents or other intellectual property rights may not be valid or sufficient to prevent them from competing.
In addition, the presence of these securities may adversely affect our terms of obtaining additional equity financing.
Reduce the likelihood that we will experience change in ownership by blocking anyone (
With the affiliate and affiliate of the person)
Approved board of directors,i)
From acquisition 4.
More than 99% of outstanding voting shares (
Defined in the Rights Plan)and (ii)
At present, there are 4 benefits.
99% or more issued voting shares do not acquire more voting shares by exercising or converting existing warrants, convertible securities or other equity --
Related securities.
In general, the revised Rights plan has not changed the rights plan in all important aspects except from 4 additions.
More than 99% to 9.
99% or more the percentage of outstanding shares of voting shares that must be beneficial to one person (
As defined in the Amended Rights Plan)
In order to trigger the right, it is limited to \"acquisition person \"(
As defined in the revised Rights Plan)
Under the Amended Rights Plan
The revised Rights plan expires on July 3, 2016.
We do not intend to pay dividends on our common stock, so any returns will be limited to the value of our stock. Item1B.
Unresolved employee reviews 2.
Property item month.
Legal action 4.
Food safety disclosure Item 5.
The market of the registrant\'s common stock and related shareholder matters and the performance chart of the issuer\'s purchase of stock securities * Item 6.
SelectedFinancial DataItem7.
Management discusses and analyzes vivoin vivosupply to provide our business partner Merck KGaA with the commercial status and operational results of Crinone for sale in more than 90 countries around the world;
Revenue from the formulation, analysis and product development capabilities of our pharmaceutical Services business Juniper Pharma Services is growing (“JPS”)
And it is possible to deploy these same features to advance our
Product candidates;
And finalize our IVR clinical animal research results for our IVR program in the first half of 2018 with the goal of finding partners for our IVR program candidates or IVR platform.
Allergan has exclusive rights to develop, manufacture and sell and commercialize these progesterone gel products in the United States.
We have also entered into a supply agreement for July 2010 with Allergan, which makes us an exclusive supplier to Crinone Allergan.
2016, royalty income includes $11.
0 million related to onetime non-
Refundable payments made by Allergan represent all future royalties payable to us.
We sell our products directly to our partner Merck KGaA and use our sales staff to sell our services worldwide.
On August 2016, we announced the assessment of COL-in Phase 2b clinical trials-
1077 does not implement its primary and secondary endpoints and COL-
Will stop 1077.
In 2017, we worked hard to advance the results of the three pre-clinical procedures and administrative costs. On November 2016, we reached an agreement with Allergan under which we received-
Time payment of $11.
Million represents all the royalties payable to us in the future.
Due to this agreement, Allergan will not pay us future royalties. Productand $8.
2 million is related to products sold by Merck KGaA through its customers, compared to $19. $8 million and $7.
4 million, respectively, for the year ended December 31, 2016.
Income for the year ended December 31, 2015 included $17.
6 million related to products shipped to Merck KGaA, $5.
3 million related to products sold by Merck KGaA through its customer service, in our service products, the number of customers has increased, and the sales focus is on larger customer contracts.
This increase is mainly due to infrastructure-related costs, including legal, accounting and other professional costs, in connection with retelling the financial results for the fiscal year ending December 31-20, 2013 to December and correcting our significant weaknesses in internal control of the financial report, costs associated with our assessment of potential strategic opportunities and other business development matters.
Fund projects are offset by net losses in foreign currency transactions related to the depreciation of the euro and sterling against the United StatesS. dollar.
This is the result of the company\'s retargeting of priority activities and our efforts to focus our resources on the core business of Crinone progesterone gel and JPS.
The reduction in fees, accounts payable and deferred income and accounts receivable is offset by an increase in inventory and prepaid expenses and other current assets.
Net cash for investment activities was $2.
EUR 8 million for the year ended December 31, 2017 was mainly due to the purchase of plant and equipment.
Net cash provided for financing activities is approximately $1.
Million for the year ended December 31, 2017, mainly related to the benefits of equipment loans and financing agreements, which were offset by the payment of the principal of the debt.
In addition, we finance certain equipment under the loan agreement and pay by March 2022.
We borrowed $0 in January and March 2017.
$9 million and $0.
Our equipment in Nottingham is £ 6 million. K. facility.
The interest rate for the two loans is 2.
December 31, 2017 for 09%.
The transaction is considered a sales failure.
Leaseback arrangements, as the company will acquire ownership of the equipment at the end of the financing period, with little or no consideration.
These failed sales
The rental arrangement has been recorded for a long time-
The company consolidated its regular debt on its balance sheet.
The initial term of the loan is 60 months.
Revenue from most of our fixed assets
The price agreement is identified based on the proportional performance method of the resulting cost ratio, which is manual-
Related to the estimated total cost of the project.
Project costs are classified as service costs and are based on the employee\'s direct salary on the project and all the direct costs incurred by completing the project, including any fees charged to us by our suppliers.
Proportional performance method for fixed-
Price contracts, because, based on historical experience and the terms set out in the contract, reasonable and reliable estimates of revenues and costs applicable to each stage of the contract can be made and indicate the level of benefits provided to our customers.
In the case of termination, repair-
Price contracts typically provide for payment of service costs as of the date of termination.
Service income also includes reimbursement, including reimbursement of travel expenses and other expenses going outof-
Pocket fees, external consultants and other reimbursed fees.
When conditions indicate that sales prices may be lower than costs due to physical deterioration, use, obsolescence, a decrease in expected future demand and a decrease in sales prices, we provide stock allowances.
We will balance the need to maintain strategic inventory levels with risks that are out of date due to changes in technology and customer demand levels.
Adverse changes in market conditions may result in the need for additional stock reserves, which may adversely affect our gross profit margin.
As at December 31, 2017, our stock allowance was $2016 and $2015.
$5 million, $45,000 and $0.
3 million respectively.
Adverse changes in market conditions may result in the need for additional stock reserves, which may adversely affect our gross profit margin.
On September 2017, we announced a corporate restructuring priority that allowed us to focus our resources on the core business of Crinone progesterone gel and Juniper Pharma Services.
As a result of this program, we revised our R & D strategy and sought potential partners with IVR projects.
As of September 18, 2017, we consider this decision to be a trigger event that requires impairment testing based on ASC 350.
Circumstances or business conditions indicate that, based on expectations for future undiscounted cash flows for each asset group, the book value of these assets may not be recoverable.
If the book value of an asset or asset group exceeds the undiscounted cash flow, we estimate the fair value of the asset, discounted cash flow analysis based on the present value of estimated future cash flow generated by asset use risk adjustment discount rate is generally used.
To estimate the fair value of the assets, we use market participant assumptions based on ASC 820 fair value measurement.
If the estimated value of the remaining useful life of intangible assets changes, we will forward-looking amortize the remaining book value of intangible assets within the remaining useful life.
Introduction payment based on PaymentEquity equity to NonemployeesAdoptedIn March 2016, Financial Accounting Standards Board (“FASB”)
Update of accounting standards (“ASU”)No. 2016-
09, compensation-
Stock compensation (Topic 718)
: Improvement of employee sharing-
Accounting based on payment (“ASU 2016-09”).
The standard aims to simplify several areas of stock accounting
Based on the remuneration arrangement, including income tax impact, classification of rewards as an equity or liability, and classification of the cash flow statement. ASU 2016-
09 is valid for the fiscal year and for the transition period in these years, starting after December 15, 2016. Income Taxes (Topic 740)
: Balance sheet classification of deferred tax can be applied retroactively or on an expected basis to all Deferred tax assets and liabilities.
We adopted the standard as of January 1, 2017.
This adoption has no significant impact on our financial position.
FASB released ASU 2017 in January 2017-simplified inventory measurement
04, simplifying the test of goodwill impairment.
The standard simplifies accounting for goodwill impairment by removing step 2 of the goodwill impairment test, which requires a hypothetical allocation of purchase prices.
The ASU shall conduct an annual or medium term goodwill impairment test effectively within the fiscal year commencing after December 15, 2019 and shall be applied on an expected basis.
The mid-term or annual goodwill impairment test is allowed on the test date after January 1, 2017.
The adoption of this standard will not have an impact on our consolidated financial statements and related disclosures.
On August 2016, FASB released ASU No. 2016-
15. classification of certain cash receipts and expenditures ,(“ASU 2016-15”)
, Fixed the guidance of ASC No
230 classification of certain items in the cash flow statement.
Main use of Asus 2016-
15 is to reduce diversity in practice by modifying guidance to add or clarify eight specific cash flow issues. ASU 2016-
15 valid for all fiscal years beginning after December 15, 2017, including the transition period during these fiscal years. ASU 2016-
15 shall be retroactively applied to all periods raised, but if the retroactively application is not feasible, it may be applied forward-looking from the earliest practicable time.
The adoption of this standard will not have an impact on our consolidated financial statements and related disclosures.
On February 2016, FASB released ASU No. 2016-02,Leases.
The new standard establishes rights. of-use (“ROU”)
A model that requires the lessee to record on the balance sheet all leased ROU assets and lease liabilities for a period of more than 12 months.
Leases will be classified as financing or operations and classification will affect the expense confirmation model in the income statement.
The new standard is valid for the fiscal year beginning after December 15, 2018, including the transition period during these fiscal years.
The earliest comparison period proposed by the lessee in the financial statements at the beginning or after the existence of capital and operating leases need to be modified retrospective transition methods, there are some practical expediency measures.
We are currently evaluating the impact of this approach on our consolidated financial statements and related disclosures.
Financial Instruments-Recognition and Measurement of financial assets and financial liabilities the adoption of this standard will not have an impact on our consolidated financial statements and related disclosures.
Revenue recognition for signing contracts with customers-Construction-
Type and production
Income from signing contracts with customers (Topic 606)
: The effective date of delaying the signing of the contract with the customer (Topic 606)
: The client\'s consideration of the agent (
Total and net reported income)and ASU No. 2016-
10. income from signing contracts with customers (Topic 606)
: Determine the performance obligations and licenses respectively, and clarify the guidance of reporting income as a principal and agent, determining the performance obligations and intellectual property licensing accounting.
In addition, the FASB released the ASU No in May 2016 and December 2016. 2016-
12. income from signing contracts with customers (Topic 606): Narrow-
Improved range and practical convenience2016-
20. technical amendments and improvements to theme 606, that is, income from signing contracts with customers, both of which amended some narrow aspects of theme 606.
The core principle of the standard is that when the company transfers the promised goods or services to the customer, the revenue will be recognized and the amount reflects the consideration that the company expects to be entitled, in exchange for these consideration goods or services.
In doing so, the company will need to use more judgment and make more estimates than under today\'s guidance.
We reviewed our historical contract and evaluated the impact of ASU 2014 --
09 requirements for its accounting policies, processes and systems.
In 2017, we finalized our assessment of the impact of the new standards brigadier general on our consolidated operations, financial position and disclosure results.
We have identified changes in the revenue recognition model of its arrangement with Merck, where the revenue record is earlier than the current guidance.
According to the current guidance, the company only acknowledges the minimum invoice price for the contract fixed or determinable at the time of delivery, and any amount earned when the amount is fixed or determinable exceeds the minimum amount, until Merck sells the product to its customers.
Under the guidance of the new proposal, the amount exceeding the contract minimum will be considered as a variable consideration and an estimate of variable considerations will be recorded at the time of delivery.
The guideline has been in effect for us since January 1, 2018 and we have adopted the standard using an improved retrospective approach.
As of January 1, 2018, we will record cumulative adjustments to reduce revenue by approximately $5.
7 million reflect the impact of the new guidance.
We also evaluated the service revenue arrangement to assess changes in the performance of obligations, variable consideration included in the transaction price, transaction price allocation based on relatively independent sales price, confirmation time, among other areas, the cost of contract acquisition and accounting disclosed in the relevant financial statements.
Under the new guidance, we did not find any significant differences in the accounting of our service revenue contracts.
We will complete these assessments in 2018 and identify and implement the necessary changes to its business processes, systems and controls to support revenue recognition and disclosure under the new standard.
However, the assessment is still in progress and further analysis may determine the impact in the future. Item 7A.
Quantitative and qualitative disclosure of market risks
Financial statements and supplementary data items 9.
Changes and disagreements with accountants on accounting and financial disclosure project 9a.
Control and process management annual report on internal control of financial reports
Integration Framework process improvement: We redesigned specific processes and controls related to reviewing contract agreements, including identifying and reviewing significant agreements with the senior management team on a quarterly basis, to ensure that relevant accounting implications are identified and considered.
In addition, we redesigned controls on R & D costs, including related balance sheet accounts.
There will be no errors or fraud, and all control issues and fraud incidents (if any) within our company will not be found ). Item9B.
Directors, executive officers and company managers of other information departments.
Perform CompensationItem12.
Security ownership of certain beneficial owners and management and related shareholders mattersitem13.
A certain relationship and related party transactions, independent directors 14.
Major accounting fees and services
List of Exhibits and Financial Statements (a)(1)(2)
Juniper Pharmaceuticals, financial statements and financial statements plan purchase and cooperation agreement for March 3, 2010
And Coventry Acquisition Co. , Ltd. (
Refer to Annex 2 for inclusion.
Registrant\'s Current Report on Form 8-K (File No. 001-10352)
Submitted on March 4, 2010)Amendment No.
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